Evaluating efficiency and statistical power of self-controlled case series and self-controlled risk interval designs in vaccine safety.

PubMed

Li, Rongxia; Stewart, Brock; Weintraub, Eric

2016-01-01

The self-controlled case series (SCCS) and self-controlled risk interval (SCRI) designs have recently become widely used in the field of post-licensure vaccine safety monitoring to detect potential elevated risks of adverse events following vaccinations. The SCRI design can be viewed as a subset of the SCCS method in that a reduced comparison time window is used for the analysis. Compared to the SCCS method, the SCRI design has less statistical power due to fewer events occurring in the shorter control interval. In this study, we derived the asymptotic relative efficiency (ARE) between these two methods to quantify this loss in power in the SCRI design. The equation is formulated as [Formula: see text] (a: control window-length ratio between SCRI and SCCS designs; b: ratio of risk window length and control window length in the SCCS design; and [Formula: see text]: relative risk of exposed window to control window). According to this equation, the relative efficiency declines as the ratio of control-period length between SCRI and SCCS methods decreases, or with an increase in the relative risk [Formula: see text]. We provide an example utilizing data from the Vaccine Safety Datalink (VSD) to study the potential elevated risk of febrile seizure following seasonal influenza vaccine in the 2010-2011 season.

Can Technology Decrease Sexual Risk Behaviors among Young People? Results of a Pilot Study Examining the Effectiveness of a Mobile Application Intervention

ERIC Educational Resources Information Center

Jackson, Dawnyéa D.; Ingram, Lucy Annang; Boyer, Cherrie B.; Robillard, Alyssa; Huhns, Michael N.

2016-01-01

College students represent an important population for studying and understanding factors that influence sexual risk given the populations' high risk of sexually transmitted infections and unintended pregnancies. Using a quasi-experimental design, the efficacy of a brief and theory-driven mobile application intervention designed to decrease sexual…

Risk-taking related to drug use: an application of the shift-to-risk design.

PubMed

Deren, S; Des Jarlais, D C

1977-01-01

The utility of the shift-to-risk design for studying the influence of peer groups on drug taking was investigated. Two studies using this design with drug content were conducted, varying the level of information provided about a drug. Subjects were from two college classes consisting of 26 and 28 students. Results indicated that the specification of possible harmful drug effects which are somewhat minimal lead to a significantly greater willingness to recommend trying the drug. In addition, a tendency for a shift-to-caution was found. It was concluded that the shift-to-risk designwas useful for studying decision-making regarding drug use, and that both users and nonusers of drugs should be included in future research.

Design of the BRISC study: a multicentre controlled clinical trial to optimize the communication of breast cancer risks in genetic counselling.

PubMed

Ockhuysen-Vermey, Caroline F; Henneman, Lidewij; van Asperen, Christi J; Oosterwijk, Jan C; Menko, Fred H; Timmermans, Daniëlle R M

2008-10-03

Understanding risks is considered to be crucial for informed decision-making. Inaccurate risk perception is a common finding in women with a family history of breast cancer attending genetic counseling. As yet, it is unclear how risks should best be communicated in clinical practice. This study protocol describes the design and methods of the BRISC (Breast cancer RISk Communication) study evaluating the effect of different formats of risk communication on the counsellee's risk perception, psychological well-being and decision-making regarding preventive options for breast cancer. The BRISC study is designed as a pre-post-test controlled group intervention trial with repeated measurements using questionnaires. The intervention-an additional risk consultation-consists of one of 5 conditions that differ in the way counsellee's breast cancer risk is communicated: 1) lifetime risk in numerical format (natural frequencies, i.e. X out of 100), 2) lifetime risk in both numerical format and graphical format (population figures), 3) lifetime risk and age-related risk in numerical format, 4) lifetime risk and age-related risk in both numerical format and graphical format, and 5) lifetime risk in percentages. Condition 6 is the control condition in which no intervention is given (usual care). Participants are unaffected women with a family history of breast cancer attending one of three participating clinical genetic centres in the Netherlands. The BRISC study allows for an evaluation of the effects of different formats of communicating breast cancer risks to counsellees. The results can be used to optimize risk communication in order to improve informed decision-making among women with a family history of breast cancer. They may also be useful for risk communication in other health-related services. Current Controlled Trials ISRCTN14566836.

Using a Regression Discontinuity Design to Determine the Effectiveness of a Vocabulary Intervention for At-Risk First-Grade Readers

ERIC Educational Resources Information Center

Ashworth, Kristen E.

2012-01-01

The purposes of this study were to determine the effectiveness of a vocabulary intervention for first-grade students at risk for reading and language difficulties and to compare the results of a regression discontinuity design to those of an experimental design. The specific research questions were: (1) Do first-graders who are at risk of reading…

Quasi-experimental study designs series-paper 6: risk of bias assessment.

PubMed

Waddington, Hugh; Aloe, Ariel M; Becker, Betsy Jane; Djimeu, Eric W; Hombrados, Jorge Garcia; Tugwell, Peter; Wells, George; Reeves, Barney

2017-09-01

Rigorous and transparent bias assessment is a core component of high-quality systematic reviews. We assess modifications to existing risk of bias approaches to incorporate rigorous quasi-experimental approaches with selection on unobservables. These are nonrandomized studies using design-based approaches to control for unobservable sources of confounding such as difference studies, instrumental variables, interrupted time series, natural experiments, and regression-discontinuity designs. We review existing risk of bias tools. Drawing on these tools, we present domains of bias and suggest directions for evaluation questions. The review suggests that existing risk of bias tools provide, to different degrees, incomplete transparent criteria to assess the validity of these designs. The paper then presents an approach to evaluating the internal validity of quasi-experiments with selection on unobservables. We conclude that tools for nonrandomized studies of interventions need to be further developed to incorporate evaluation questions for quasi-experiments with selection on unobservables. Copyright © 2017 Elsevier Inc. All rights reserved.

Proof of Concept in Disrupted Tactical Networking

DTIC Science & Technology

2017-09-01

because of the risk of detection. In this study , we design projectile-based mesh networking prototypes as one potential type of short-living network...to communicate because of the risk of detection. In this study , we design projectile-based mesh networking prototypes as one potential type of short...reader with a background in systems-theory. This study is designed using systems theory and uses systems theory as a lens through which to observe

Study designs for identifying risk compensation behavior among users of biomedical HIV prevention technologies: balancing methodological rigor and research ethics.

PubMed

Underhill, Kristen

2013-10-01

The growing evidence base for biomedical HIV prevention interventions - such as oral pre-exposure prophylaxis, microbicides, male circumcision, treatment as prevention, and eventually prevention vaccines - has given rise to concerns about the ways in which users of these biomedical products may adjust their HIV risk behaviors based on the perception that they are prevented from infection. Known as risk compensation, this behavioral adjustment draws on the theory of "risk homeostasis," which has previously been applied to phenomena as diverse as Lyme disease vaccination, insurance mandates, and automobile safety. Little rigorous evidence exists to answer risk compensation concerns in the biomedical HIV prevention literature, in part because the field has not systematically evaluated the study designs available for testing these behaviors. The goals of this Commentary are to explain the origins of risk compensation behavior in risk homeostasis theory, to reframe risk compensation as a testable response to the perception of reduced risk, and to assess the methodological rigor and ethical justification of study designs aiming to isolate risk compensation responses. Although the most rigorous methodological designs for assessing risk compensation behavior may be unavailable due to ethical flaws, several strategies can help investigators identify potential risk compensation behavior during Phase II, Phase III, and Phase IV testing of new technologies. Where concerns arise regarding risk compensation behavior, empirical evidence about the incidence, types, and extent of these behavioral changes can illuminate opportunities to better support the users of new HIV prevention strategies. This Commentary concludes by suggesting a new way to conceptualize risk compensation behavior in the HIV prevention context. Copyright © 2013 Elsevier Ltd. All rights reserved.

Study designs for identifying risk compensation behavior among users of biomedical HIV prevention technologies: Balancing methodological rigor and research ethics

PubMed Central

Underhill, Kristen

2014-01-01

The growing evidence base for biomedical HIV prevention interventions – such as oral pre-exposure prophylaxis, microbicides, male circumcision, treatment as prevention, and eventually prevention vaccines – has given rise to concerns about the ways in which users of these biomedical products may adjust their HIV risk behaviors based on the perception that they are prevented from infection. Known as risk compensation, this behavioral adjustment draws on the theory of “risk homeostasis,” which has previously been applied to phenomena as diverse as Lyme disease vaccination, insurance mandates, and automobile safety. Little rigorous evidence exists to answer risk compensation concerns in the biomedical HIV prevention literature, in part because the field has not systematically evaluated the study designs available for testing these behaviors. The goals of this Commentary are to explain the origins of risk compensation behavior in risk homeostasis theory, to reframe risk compensation as a testable response to the perception of reduced risk, and to assess the methodological rigor and ethical justification of study designs aiming to isolate risk compensation responses. Although the most rigorous methodological designs for assessing risk compensation behavior may be unavailable due to ethical flaws, several strategies can help investigators identify potential risk compensation behavior during Phase II, Phase III, and Phase IV testing of new technologies. Where concerns arise regarding risk compensation behavior, empirical evidence about the incidence, types, and extent of these behavioral changes can illuminate opportunities to better support the users of new HIV prevention strategies. This Commentary concludes by suggesting a new way to conceptualize risk compensation behavior in the HIV prevention context. PMID:23597916

Advanced Technology Spark-Ignition Aircraft Piston Engine Design Study

NASA Technical Reports Server (NTRS)

Stuckas, K. J.

1980-01-01

The advanced technology, spark ignition, aircraft piston engine design study was conducted to determine the improvements that could be made by taking advantage of technology that could reasonably be expected to be made available for an engine intended for production by January 1, 1990. Two engines were proposed to account for levels of technology considered to be moderate risk and high risk. The moderate risk technology engine is a homogeneous charge engine operating on avgas and offers a 40% improvement in transportation efficiency over present designs. The high risk technology engine, with a stratified charge combustion system using kerosene-based jet fuel, projects a 65% improvement in transportation efficiency. Technology enablement program plans are proposed herein to set a timetable for the successful integration of each item of required advanced technology into the engine design.

PRA and Conceptual Design

NASA Technical Reports Server (NTRS)

DeMott, Diana; Fuqua, Bryan; Wilson, Paul

2013-01-01

Once a project obtains approval, decision makers have to consider a variety of alternative paths for completing the project and meeting the project objectives. How decisions are made involves a variety of elements including: cost, experience, current technology, ideologies, politics, future needs and desires, capabilities, manpower, timing, available information, and for many ventures management needs to assess the elements of risk versus reward. The use of high level Probabilistic Risk Assessment (PRA) Models during conceptual design phases provides management with additional information during the decision making process regarding the risk potential for proposed operations and design prototypes. The methodology can be used as a tool to: 1) allow trade studies to compare alternatives based on risk, 2) determine which elements (equipment, process or operational parameters) drives the risk, and 3) provide information to mitigate or eliminate risks early in the conceptual design to lower costs. Creating system models using conceptual design proposals and generic key systems based on what is known today can provide an understanding of the magnitudes of proposed systems and operational risks and facilitates trade study comparisons early in the decision making process. Identifying the "best" way to achieve the desired results is difficult, and generally occurs based on limited information. PRA provides a tool for decision makers to explore how some decisions will affect risk before the project is committed to that path, which can ultimately save time and money.

Impact of task design on task performance and injury risk: case study of a simulated drilling task.

PubMed

Alabdulkarim, Saad; Nussbaum, Maury A; Rashedi, Ehsan; Kim, Sunwook; Agnew, Michael; Gardner, Richard

2017-06-01

Existing evidence is limited regarding the influence of task design on performance and ergonomic risk, or the association between these two outcomes. In a controlled experiment, we constructed a mock fuselage to simulate a drilling task common in aircraft manufacturing, and examined the effect of three levels of workstation adjustability on performance as measured by productivity (e.g. fuselage completion time) and quality (e.g. fuselage defective holes), and ergonomic risk as quantified using two common methods (rapid upper limb assessment and the strain index). The primary finding was that both productivity and quality significantly improved with increased adjustability, yet this occurred only when that adjustability succeeded in reducing ergonomic risk. Supporting the inverse association between ergonomic risk and performance, the condition with highest adjustability created the lowest ergonomic risk and the best performance while there was not a substantial difference in ergonomic risk between the other two conditions, in which performance was also comparable. Practitioner Summary: Findings of this study supported a causal relationship between task design and both ergonomic risk and performance, and that ergonomic risk and performance are inversely associated. While future work is needed under more realistic conditions and a broader population, these results may be useful for task (re)design and to help cost-justify some ergonomic interventions.

Evaluating Risk Communication After the Fukushima Disaster Based on Nudge Theory.

PubMed

Murakami, Michio; Tsubokura, Masaharu

2017-03-01

Using nudge theory and some examples of risk communication that followed the Fukushima disaster, this article discusses the influences and justifications of risk communication, in addition to how risk communication systems are designed. To assist people in making decisions based on their own value systems, we provide three suggestions, keeping in mind that people can be influenced (ie, "nudged") depending on how risk communication takes place: (1) accumulate knowledge on the process of evaluating how the method of risk communication and a system's default design could impact people; (2) clarify the purpose and outcomes of risk communication; and (3) see what risk communication might be ethically unjustifiable. Quantitative studies on risk communication and collective narratives will provide some ideas for how to design better risk communication systems and to help people make decisions. Furthermore, we have shown examples of unjustifiable risk communication.

Quantifying the impact of time-varying baseline risk adjustment in the self-controlled risk interval design.

PubMed

Li, Lingling; Kulldorff, Martin; Russek-Cohen, Estelle; Kawai, Alison Tse; Hua, Wei

2015-12-01

The self-controlled risk interval design is commonly used to assess the association between an acute exposure and an adverse event of interest, implicitly adjusting for fixed, non-time-varying covariates. Explicit adjustment needs to be made for time-varying covariates, for example, age in young children. It can be performed via either a fixed or random adjustment. The random-adjustment approach can provide valid point and interval estimates but requires access to individual-level data for an unexposed baseline sample. The fixed-adjustment approach does not have this requirement and will provide a valid point estimate but may underestimate the variance. We conducted a comprehensive simulation study to evaluate their performance. We designed the simulation study using empirical data from the Food and Drug Administration-sponsored Mini-Sentinel Post-licensure Rapid Immunization Safety Monitoring Rotavirus Vaccines and Intussusception study in children 5-36.9 weeks of age. The time-varying confounder is age. We considered a variety of design parameters including sample size, relative risk, time-varying baseline risks, and risk interval length. The random-adjustment approach has very good performance in almost all considered settings. The fixed-adjustment approach can be used as a good alternative when the number of events used to estimate the time-varying baseline risks is at least the number of events used to estimate the relative risk, which is almost always the case. We successfully identified settings in which the fixed-adjustment approach can be used as a good alternative and provided guidelines on the selection and implementation of appropriate analyses for the self-controlled risk interval design. Copyright © 2015 John Wiley & Sons, Ltd.

Perception of risks from electromagnetic fields: A psychometric evaluation of a risk-communication approach

DOE Office of Scientific and Technical Information (OSTI.GOV)

MacGregor, D.G.; Slovic, P.; Morgan, M.G.

Potential health risks from exposure to power-frequency electromagnetic fields (EMF) have become an issue of significant public concern. This study evaluates a brochure designed to communicate EMF health risks from a scientific perspective. The study utilized a pretest-posttest design in which respondents judged various sources of EMF (and other) health and safety risks, both before reaching the brochure and after. Respondents assessed risks on dimensions similar to those utilized in previous studies of risk perception. In addition, detailed ratings were made that probed respondents' beliefs about the possible causal effects of EMF exposure. The findings suggest that naive beliefs aboutmore » the potential of EMF exposure to cause harm were highly influenced by specific content elements of the brochure. The implications for using risk-communication approaches based on communicating scientific uncertainty are discussed. 19 refs., 1 fig., 11 tabs.« less

Implementation of "Quality by Design (QbD)" Approach for the Development of 5-Fluorouracil Loaded Thermosensitive Hydrogel.

PubMed

Dalwadi, Chintan; Patel, Gayatri

2016-01-01

The purpose of this study was to investigate Quality by Design (QbD) principle for the preparation of hydrogel products to prove both practicability and utility of executing QbD concept to hydrogel based controlled release systems. Product and process understanding will help in decreasing the variability of critical material and process parameters, which give quality product output and reduce the risk. This study includes the identification of the Quality Target Product Profiles (QTPPs) and Critical Quality Attributes (CQAs) from literature or preliminary studies. To identify and control the variability in process and material attributes, two tools of QbD was utilized, Quality Risk Management (QRM) and Experimental Design. Further, it helps to identify the effect of these attributes on CQAs. Potential risk factors were identified from fishbone diagram and screened by risk assessment and optimized by 3-level 2- factor experimental design with center points in triplicate, to analyze the precision of the target process. This optimized formulation was further characterized by gelling time, gelling temperature, rheological parameters, in-vitro biodegradation and in-vitro drug release. Design space was created using experimental design tool that gives the control space and working within this controlled space reduces all the failure modes below the risk level. In conclusion, QbD approach with QRM tool provides potent and effectual pyramid to enhance the quality into the hydrogel.

Incorporating Risk Assessment and Inherently Safer Design Practices into Chemical Engineering Education

ERIC Educational Resources Information Center

Seay, Jeffrey R.; Eden, Mario R.

2008-01-01

This paper introduces, via case study example, the benefit of including risk assessment methodology and inherently safer design practices into the curriculum for chemical engineering students. This work illustrates how these tools can be applied during the earliest stages of conceptual process design. The impacts of decisions made during…

78 FR 65326 - Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-31

... Directed at Adolescents.'' This study is designed to examine how adolescents interpret DTC advertising... understanding of benefits and risks in DTC ads differ across this part of the lifespan. Design Overview Within... (benefit onset: immediate, delayed) x 2 (risk severity: high, low) factorial design, based on the rationale...

Empowering At-Risk Students through Appreciative Inquiry

ERIC Educational Resources Information Center

San Martin, Teresa L.; Calabrese, Raymond L.

2011-01-01

Purpose: The purpose of this study is to identify how at-risk high school students in an alternative school describe how they best learn and to extrapolate their preferred learning practices to improve teacher pedagogical practices. Design/methodology/approach: The authors used a qualitative case study design to facilitate the first two stages of…

A New Time-varying Concept of Risk in a Changing Climate.

PubMed

Sarhadi, Ali; Ausín, María Concepción; Wiper, Michael P

2016-10-20

In a changing climate arising from anthropogenic global warming, the nature of extreme climatic events is changing over time. Existing analytical stationary-based risk methods, however, assume multi-dimensional extreme climate phenomena will not significantly vary over time. To strengthen the reliability of infrastructure designs and the management of water systems in the changing environment, multidimensional stationary risk studies should be replaced with a new adaptive perspective. The results of a comparison indicate that current multi-dimensional stationary risk frameworks are no longer applicable to projecting the changing behaviour of multi-dimensional extreme climate processes. Using static stationary-based multivariate risk methods may lead to undesirable consequences in designing water system infrastructures. The static stationary concept should be replaced with a flexible multi-dimensional time-varying risk framework. The present study introduces a new multi-dimensional time-varying risk concept to be incorporated in updating infrastructure design strategies under changing environments arising from human-induced climate change. The proposed generalized time-varying risk concept can be applied for all stochastic multi-dimensional systems that are under the influence of changing environments.

HEALTHY study rationale, design and methods: Moderating risk of type 2 diabetes in multi-ethnic middle school students

USDA-ARS?s Scientific Manuscript database

The HEALTHY primary prevention trial was designed and implemented in response to the growing numbers of children and adolescents being diagnosed with type 2 diabetes. The objective was to moderate risk factors for type 2 diabetes. Modifiable risk factors measured were indicators of adiposity and gly...

Rapid Response Risk Assessment in New Project Development

NASA Technical Reports Server (NTRS)

Graber, Robert R.

2010-01-01

A capability for rapidly performing quantitative risk assessments has been developed by JSC Safety and Mission Assurance for use on project design trade studies early in the project life cycle, i.e., concept development through preliminary design phases. A risk assessment tool set has been developed consisting of interactive and integrated software modules that allow a user/project designer to assess the impact of alternative design or programmatic options on the probability of mission success or other risk metrics. The risk and design trade space includes interactive options for selecting parameters and/or metrics for numerous design characteristics including component reliability characteristics, functional redundancy levels, item or system technology readiness levels, and mission event characteristics. This capability is intended for use on any project or system development with a defined mission, and an example project will used for demonstration and descriptive purposes, e.g., landing a robot on the moon. The effects of various alternative design considerations and their impact of these decisions on mission success (or failure) can be measured in real time on a personal computer. This capability provides a high degree of efficiency for quickly providing information in NASA s evolving risk-based decision environment

NASA's International Lunar Network Anchor Nodes and Robotic Lunar Lander Project Update

NASA Technical Reports Server (NTRS)

Cohen, Barbara A.; Bassler, Julie A.; Ballard, Benjamin; Chavers, Greg; Eng, Doug S.; Hammond, Monica S.; Hill, Larry A.; Harris, Danny W.; Hollaway, Todd A.; Kubota, Sanae;

Evaluation of Psychological Hardiness and Coping Style as Risk/Resilience Factors for Health Risk Behaviour

DTIC Science & Technology

2011-04-01

205 RESEARCH DESIGN & METHODS Objective/Hypothesis: The objective of the study is to evaluate the utility of a short hardiness-resilience...problems. Study Design & Methods : This research will evaluate the utility of hardiness, as measured by the DRS-15R, as a screening tool for...may take a toll on defense workers. This research points the way to new approaches for early identification of military workers at risk for stress

Design risk assessment for burst-prone mines: Application in a Canadian mine

NASA Astrophysics Data System (ADS)

Cheung, David J.

A proactive stance towards improving the effectiveness and consistency of risk assessments has been adopted recently by mining companies and industry. The next 10-20 years forecasts that ore deposits accessible using shallow mining techniques will diminish. The industry continues to strive for success in "deeper" mining projects in order to keep up with the continuing demand for raw materials. Although the returns are quite profitable, many projects have been sidelined due to high uncertainty and technical risk in the mining of the mineral deposit. Several hardrock mines have faced rockbursting and seismicity problems. Within those reported, mines in countries like South Africa, Australia and Canada have documented cases of severe rockburst conditions attributed to the mining depth. Severe rockburst conditions known as "burst-prone" can be effectively managed with design. Adopting a more robust design can ameliorate the exposure of workers and equipment to adverse conditions and minimize the economic consequences, which can hinder the bottom line of an operation. This thesis presents a methodology created for assessing the design risk in burst-prone mines. The methodology includes an evaluation of relative risk ratings for scenarios with options of risk reduction through several design principles. With rockbursts being a hazard of seismic events, the methodology is based on research in the area of mining seismicity factoring in rockmass failure mechanisms, which results from a combination of mining induced stress, geological structures, rockmass properties and mining influences. The methodology was applied to case studies at Craig Mine of Xstrata Nickel in Sudbury, Ontario, which is known to contain seismically active fault zones. A customized risk assessment was created and applied to rockburst case studies, evaluating the seismic vulnerability and consequence for each case. Application of the methodology to Craig Mine demonstrates that changes in the design can reduce both exposure risk (personnel and equipment), and economical risk (revenue and costs). Fatal and catastrophic consequences can be averted through robust planning and design. Two customized approaches were developed to conduct risk assessment of case studies at Craig Mine. Firstly, the Brownfield Approach utilizes the seismic database to determine the seismic hazard from a rating system that evaluates frequency-magnitude, event size, and event-blast relation. Secondly, the Greenfield Approach utilizes the seismic database, focusing on larger magnitude events, rocktype, and geological structure. The customized Greenfield Approach can also be applied in the evaluation of design risk in deep mines with the same setting and condition as Craig Mine. Other mines with different settings and conditions can apply the principles in the methodology to evaluate design alternatives and risk reduction strategies for burst-prone mines.

Using base rates and correlational data to supplement clinical risk assessments.

PubMed

Davis, Jaya; Sorensen, Jon R

2013-01-01

The current study is a partial replication of previous studies designed to estimate the level of risk posed by capital murder defendants. The study draws on data describing the behavior of nearly 2,000 incarcerated capital murderers to forecast violence propensity among defendants sentenced to life imprisonment. Logistic regression is used to model various violence outcomes, relying on the following predictors: age, educational attainment, prior imprisonment, and gang affiliation. This exercise is designed to illustrate how actuarial data may be used to anchor individualized clinical assessments of risk in capital murder trials.

Perspectives in adolescent risk-taking through instrument development.

PubMed

Busen, N H; Kouzekanani, K

2000-01-01

Understanding the high-risk adolescent's perception of risk taking is essential for health professionals to determine appropriate interventions. The purpose of this study was to examine the psychometric properties of the revised Adolescent Risk-Taking Instrument (ARTI) designed to measure the high-risk adolescent's perception of risk taking. This study also examined the variables that are most predictive of social adaptation and risk taking. An ex post facto design was used to standardize data collection and to assess the psychometric properties of the revised ARTI. The nonprobability sample consisted of 167 adolescents attending school in an urban, health-underserved area. Exploratory factor analysis supported construct validity, and Chronbach's Coefficient Alpha supported internal consistency reliability. The reliability coefficient for the risk taking and social adaptation constructs were .80 and .77, respectively. Current perspectives on adolescent risk taking and implications for the use of the ARTI in clinical practice are addressed.

Development and Psychometric Evaluation of the Reasons for Living-Older Adults Scale: A Suicide Risk Assessment Inventory

ERIC Educational Resources Information Center

Edelstein, Barry A.; Heisel, Marnin J.; McKee, Deborah R.; Martin, Ronald R.; Koven, Lesley P.; Duberstein, Paul R.; Britton, Peter C.

2009-01-01

Purpose: The purposes of these studies were to develop and initially evaluate the psychometric properties of the Reasons for Living Scale-Older Adult version (RFL-OA), an older adults version of a measure designed to assess reasons for living among individuals at risk for suicide. Design and Methods: Two studies are reported. Study 1 involved…

Risk Factors for Road Transport-Related Injury among Pedestrians in Rural Ghana: Implications for Road Safety Education

ERIC Educational Resources Information Center

Teye-Kwadjo, Enoch

2017-01-01

Objectives: Injuries and mortality resulting from pedestrian road traffic crashes are a major public health problem in Ghana. This study investigated risk factors for road transport-related injury among pedestrians in rural Ghana. Design: Case study design using qualitative data. Method: In-depth interviews were conducted with pedestrians.…

Application of quality by design (QbD) to formulation and processing of naproxen pellets by extrusion-spheronization.

PubMed

Wang, Junlin; Kan, Shuling; Chen, Tong; Liu, Jianping

2015-03-01

The aim of this research was to apply quality by design (QbD) to the development of naproxen loaded core pellets which can be used as the potential core for colon-specific pellets. In the early stages of this study, prior knowledge and preliminary studies were systematically incorporated into the risk assessment using failure mode and effect analysis (FMEA) and fishbone diagram. Then Plackett-Burman design was used to screen eight potential high risk factors (spheronization speed, spheronization time, extrusion speed, drying method, CCMC-Na concentration, lactose concentration, water concentration and Tween 80 concentration) obtained from the above risk assessment. It was discovered that out of the eight potential high risk factors only three factors (spheronization speed, extrusion speed and CCMC-Na concentration) had significant effects on the quality of the pellets. This allowed the use of Box-Behnken design (BBD) to fully elucidate the relationship between the variables and critical quality attribute (CQA). Finally, the final control space was established within which the quality of the pellets can meet the requirement of colon-specific drug delivery system. This study demonstrated that naproxen loaded core pellets were successfully designed using QbD principle.

77 FR 28883 - Cooperative Agreement To Support Innovation in Vaccine Clinical Trial Design and Collaboration in...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-16

... years there has been interest in finding innovative study designs to speed development of promising new... various types of adaptive trial designs and other innovations in clinical study designs. 2. Improving... of study designs, individual risk perception, and vaccination choice. One approach to obtain this...

Evaluating the Impact of Database Heterogeneity on Observational Study Results

PubMed Central

Madigan, David; Ryan, Patrick B.; Schuemie, Martijn; Stang, Paul E.; Overhage, J. Marc; Hartzema, Abraham G.; Suchard, Marc A.; DuMouchel, William; Berlin, Jesse A.

2013-01-01

Clinical studies that use observational databases to evaluate the effects of medical products have become commonplace. Such studies begin by selecting a particular database, a decision that published papers invariably report but do not discuss. Studies of the same issue in different databases, however, can and do generate different results, sometimes with strikingly different clinical implications. In this paper, we systematically study heterogeneity among databases, holding other study methods constant, by exploring relative risk estimates for 53 drug-outcome pairs and 2 widely used study designs (cohort studies and self-controlled case series) across 10 observational databases. When holding the study design constant, our analysis shows that estimated relative risks range from a statistically significant decreased risk to a statistically significant increased risk in 11 of 53 (21%) of drug-outcome pairs that use a cohort design and 19 of 53 (36%) of drug-outcome pairs that use a self-controlled case series design. This exceeds the proportion of pairs that were consistent across databases in both direction and statistical significance, which was 9 of 53 (17%) for cohort studies and 5 of 53 (9%) for self-controlled case series. Our findings show that clinical studies that use observational databases can be sensitive to the choice of database. More attention is needed to consider how the choice of data source may be affecting results. PMID:23648805

Effectiveness and uptake of screening programmes for coronary heart disease and diabetes: a realist review of design components used in interventions

PubMed Central

Holland, Carol; Cooper, Yvonne; Shaw, Rachel; Pattison, Helen; Cooke, Richard

2013-01-01

Objective To evaluate behavioural components and strategies associated with increased uptake and effectiveness of screening for coronary heart disease and diabetes with an implementation science focus. Design Realist review. Data sources PubMed, Web of Knowledge, Cochrane Database of Systematic Reviews, Cochrane Controlled Trials Register and reference chaining. Searches limited to English language studies published since 1990. Eligibility criteria Eligible studies evaluated interventions designed to increase the uptake of cardiovascular disease (CVD) and diabetes screening and examined behavioural and/or strategic designs. Studies were excluded if they evaluated changes in risk factors or cost-effectiveness only. Results In 12 eligible studies, several different intervention designs and evidence-based strategies were evaluated. Salient themes were effects of feedback on behaviour change or benefits of health dialogues over simple feedback. Studies provide mixed evidence about the benefits of these intervention constituents, which are suggested to be situation and design specific, broadly supporting their use, but highlighting concerns about the fidelity of intervention delivery, raising implementation science issues. Three studies examined the effects of informed choice or loss versus gain frame invitations, finding no effect on screening uptake but highlighting opportunistic screening as being more successful for recruiting higher CVD and diabetes risk patients than an invitation letter, with no differences in outcomes once recruited. Two studies examined differences between attenders and non-attenders, finding higher risk factors among non-attenders and higher diagnosed CVD and diabetes among those who later dropped out of longitudinal studies. Conclusions If the risk and prevalence of these diseases are to be reduced, interventions must take into account what we know about effective health behaviour change mechanisms, monitor delivery by trained professionals and examine the possibility of tailoring programmes according to contexts such as risk level to reach those most in need. Further research is needed to determine the best strategies for lifelong approaches to screening. PMID:24202056

NASA Propulsion Concept Studies and Risk Reduction Activities for Resource Prospector Lander

NASA Technical Reports Server (NTRS)

Trinh, Huu P.; Williams, Hunter; Burnside, Chris

2015-01-01

The trade study has led to the selection of propulsion concept with the lowest cost and net lowest risk -Government-owned, flight qualified components -Meet mission requirements although the configuration is not optimized. Risk reduction activities have provided an opportunity -Implement design improvements while development with the early-test approach. -Gain knowledge on the operation and identify operation limit -Data to anchor analytical models for future flight designs; The propulsion system cold flow tests series have provided valuable data for future design. -The pressure surge from the system priming and waterhammer within component operation limits. -Enable to optimize the ullage volume to reduce the propellant tank mass; RS-34 hot fire tests have successfully demonstrated of using the engines for the RP mission -No degradation of performance due to extended storage life of the hardware. -Enable to operate the engine for RP flight mission scenarios, outside of the qualification regime. -Provide extended data for the thermal and GNC designs. Significant progress has been made on NASA propulsion concept design and risk reductions for Resource Prospector lander.

How effective are risk assessments/measures for predicting future aggressive behaviour in adults with intellectual disabilities (ID): A systematic review and meta-analysis.

PubMed

Lofthouse, Rachael; Golding, Laura; Totsika, Vasiliki; Hastings, Richard; Lindsay, William

2017-12-01

Risk assessments assist professionals in the identification and management of risk of aggression. The present study aimed to systematically review evidence on the efficacy of assessments for managing the risk of physical aggression in adults with intellectual disabilities (ID). A literature search was conducted using the databases PsycINFO, EMBASE, MEDLINE, Web of Science, and Google Scholar. Electronic and hand searches identified 14 studies that met the inclusion criteria. Standardised mean difference effect sizes Area Under Curve (AUC) were calculated for studies. Random effects subgroup analysis was used to compare different types of risk measures (Actuarial, Structured Professional Judgment and dynamic), and prospective vs. catch-up longitudinal study designs. Overall, evidence of predictive validity was found for risk measures with ID populations: (AUC)=0.724, 95% CI [0.681, 0.768]. There was no variation in the performance of different types of risk measures, or different study design. Risk assessment measures predict the likelihood of aggression in ID population and are comparable to those in mainstream populations. Further meta-analysis is necessary when risk measures are more established in this population. Copyright © 2017 Elsevier Ltd. All rights reserved.

Hydrologic Extremes and Risk Assessment under Non-stationarity

NASA Astrophysics Data System (ADS)

Mondal, A.

2015-12-01

In the context of hydrologic designs, robust assessment and communication of risk is crucial to ascertain a sustainable water future. Traditional methods for defining return period, risk or reliability assumes a stationary regime which may no longer be valid because of natural or man-made changes. Reformulations are suggested in recent literature to account for non-stationarity in the definition of hydrologic risk, as time evolves. This study presents a comparative analysis of design levels under non-stationarity based on time varying annual exceedance probabilities, waiting time of a hazardous event, number of hazardous events and probability of failure. A case study application is shown for peak streamflow in the flood-prone delta area of the Krishna River in India where an increasing trend in annual maximum flows are observed owing to persistent silting. Considerable disagreement is found between the design magnitudes of flood obtained by the different definitions of hydrologic risk. Such risk is also found to be highly sensitive to the assumed design life period and projections of trend in that period or beyond. Additionally, some critical points on the assumption of a deterministic non-stationary model for an observed natural process are also discussed. The findings highlight the necessity for a unifying framework for assessment and communication of hydrologic risk under transient hydro-climatic conditions. The concepts can also be extended to other applications such as regional hydrologic frequency analysis or development of precipitation intensity-duration-frequency relationships for infrastructure design.

Risk management for the Space Exploration Initiative

NASA Technical Reports Server (NTRS)

Buchbinder, Ben

1993-01-01

Probabilistic Risk Assessment (PRA) is a quantitative engineering process that provides the analytic structure and decision-making framework for total programmatic risk management. Ideally, it is initiated in the conceptual design phase and used throughout the program life cycle. Although PRA was developed for assessment of safety, reliability, and availability risk, it has far greater application. Throughout the design phase, PRA can guide trade-off studies among system performance, safety, reliability, cost, and schedule. These studies are based on the assessment of the risk of meeting each parameter goal, with full consideration of the uncertainties. Quantitative trade-off studies are essential, but without full identification, propagation, and display of uncertainties, poor decisions may result. PRA also can focus attention on risk drivers in situations where risk is too high. For example, if safety risk is unacceptable, the PRA prioritizes the risk contributors to guide the use of resources for risk mitigation. PRA is used in the Space Exploration Initiative (SEI) Program. To meet the stringent requirements of the SEI mission, within strict budgetary constraints, the PRA structure supports informed and traceable decision-making. This paper briefly describes the SEI PRA process.

Epidemiology of non-submersion injuries in aquatic sporting and recreational activities.

PubMed

Chalmers, David; Morrison, Luke

2003-01-01

Although the issues of drowning and near-drowning in aquatic sporting and recreational activities receive considerable attention in the epidemiological literature, there is not a recognised literature on non-submersion injuries occurring in these activities. This review draws together the epidemiological literature on non-submersion injuries and describes the incidence, nature and causes of these injuries, common risk factors, and strategies for prevention. Activities covered by the review include swimming, diving, boating, surf sports, fishing, water polo and water sliding. For most activities there is a dearth of good quality descriptive studies, with most involving cases-series designs and few providing estimates of incidence. Inconsistencies in inclusion criteria and the reporting of incidence rates makes comparisons within and between activities difficult. Incidence rates were identified for most activities and in general the incidence of injury was low, especially for more serious injury. However, some activities were associated with severely disabling injury, such as spinal cord injury (diving) and amputation (from propeller strikes in water skiing and swimming). Only three studies reporting the significance of postulated risk factors were identified. Lack of knowledge about the water being entered and alcohol consumption are significant risk factors in recreational diving; increased blood alcohol concentrations were reported to increase the risk of death in boating; and obesity and tandem riding were reported to increase the risk of injury on public water slides. Few evaluations of preventive measures were identified. Two studies reported reductions in the incidence of water slide injuries following the introduction of design changes and supervision, but neither had a non-intervention comparison group. Improvements in swimming and diving skills were reported in three studies, but these were not designed to measure changes in the risk of injury.This review demonstrates that there is a need for well-designed epidemiological research on non-submersion injury in aquatic sporting and recreational activities. The first priority should be for studies designed to describe accurately the incidence, nature, severity and circumstances of these injuries, followed by research on the significance of postulated risk factors. Once this research has been undertaken, interventions targeted at reducing the incidence of injury in aquatic sporting and recreational activities can be designed and evaluated.

The effect of graphical and numerical presentation of hypothetical prenatal diagnosis results on risk perception.

PubMed

Siegrist, Michael; Orlow, Pascale; Keller, Carmen

2008-01-01

To evaluate various formats for the communication of prenatal test results. In study 1 (N=400), female students completed a questionnaire assessing risk perception, affect, and perceived usefulness of prenatal test results. A randomized, 2 (risk level; low, high) x 4 (format; ratio with numerator 1, ratio with denominator 1000, Paling Perspective Scale, pictograms) design was used. Study 2 (N=200) employed a 2 (risk level; low, high) x 2 (format; Paling Perspective Scale, risk comparisons in numerical format) design. In study 1, the Paling Perspective Scale resulted in a higher level of perceived risk across different risk levels compared with the other formats. Furthermore, participants in the low-risk group perceived the test results as less risky compared with participants in the high-risk group (P < 0.001) when the Paling Perspective Scale was used. No significant differences between low and high risks were observed for the other 3 formats. In study 2, the Paling Perspective Scale evoked higher levels of perceived risks relative to the numerical presentation of risk comparisons. For both formats, we found that participants confronted with a high risk perceived test results as more risky compared with participants confronted with a low risk. The Paling Perspective Scale resulted in a higher level of perceived risk compared with the other formats. This effect must be taken into account when choosing a graphical or numerical format for risk communication.

Development of a Premium Quality Plasma-derived IVIg (IQYMUNE®) Utilizing the Principles of Quality by Design-A Worked-through Case Study.

PubMed

Paolantonacci, Philippe; Appourchaux, Philippe; Claudel, Béatrice; Ollivier, Monique; Dennett, Richard; Siret, Laurent

2018-01-01

Polyvalent human normal immunoglobulins for intravenous use (IVIg), indicated for rare and often severe diseases, are complex plasma-derived protein preparations. A quality by design approach has been used to develop the Laboratoire Français du Fractionnement et des Biotechnologies new-generation IVIg, targeting a high level of purity to generate an enhanced safety profile while maintaining a high level of efficacy. A modular approach of quality by design was implemented consisting of five consecutive steps to cover all the stages from the product design to the final product control strategy.A well-defined target product profile was translated into 27 product quality attributes that formed the basis of the process design. In parallel, a product risk analysis was conducted and identified 19 critical quality attributes among the product quality attributes. Process risk analysis was carried out to establish the links between process parameters and critical quality attributes. Twelve critical steps were identified, and for each of these steps a risk mitigation plan was established.Among the different process risk mitigation exercises, five process robustness studies were conducted at qualified small scale with a design of experiment approach. For each process step, critical process parameters were identified and, for each critical process parameter, proven acceptable ranges were established. The quality risk management and risk mitigation outputs, including verification of proven acceptable ranges, were used to design the process verification exercise at industrial scale.Finally, the control strategy was established using a mix, or hybrid, of the traditional approach plus elements of the quality by design enhanced approach, as illustrated, to more robustly assign material and process controls and in order to securely meet product specifications.The advantages of this quality by design approach were improved process knowledge for industrial design and process validation and a clear justification of the process and product specifications as a basis for control strategy and future comparability exercises. © PDA, Inc. 2018.

Exploration Spacecraft and Space Suit Internal Atmosphere Pressure and Composition

NASA Technical Reports Server (NTRS)

Lange, Kevin; Duffield, Bruce; Jeng, Frank; Campbell, Paul

2005-01-01

The design of habitat atmospheres for future space missions is heavily driven by physiological and safety requirements. Lower EVA prebreathe time and reduced risk of decompression sickness must be balanced against the increased risk of fire and higher cost and mass of materials associated with higher oxygen concentrations. Any proposed increase in space suit pressure must consider impacts on space suit mass and mobility. Future spacecraft designs will likely incorporate more composite and polymeric materials both to reduce structural mass and to optimize crew radiation protection. Narrowed atmosphere design spaces have been identified that can be used as starting points for more detailed design studies and risk assessments.

A comprehensive risk assessment framework for offsite transportation of inflammable hazardous waste.

PubMed

Das, Arup; Gupta, A K; Mazumder, T N

2012-08-15

A framework for risk assessment due to offsite transportation of hazardous wastes is designed based on the type of event that can be triggered from an accident of a hazardous waste carrier. The objective of this study is to design a framework for computing the risk to population associated with offsite transportation of inflammable and volatile wastes. The framework is based on traditional definition of risk and is designed for conditions where accident databases are not available. The probability based variable in risk assessment framework is substituted by a composite accident index proposed in this study. The framework computes the impacts due to a volatile cloud explosion based on TNO Multi-energy model. The methodology also estimates the vulnerable population in terms of disability adjusted life years (DALY) which takes into consideration the demographic profile of the population and the degree of injury on mortality and morbidity sustained. The methodology is illustrated using a case study of a pharmaceutical industry in the Kolkata metropolitan area. Copyright © 2012 Elsevier B.V. All rights reserved.

Modifications to risk-targeted seismic design maps for subduction and near-fault hazards

USGS Publications Warehouse

Liel, Abbie B.; Luco, Nicolas; Raghunandan, Meera; Champion, C.; Haukaas, Terje

2015-01-01

ASCE 7-10 introduced new seismic design maps that define risk-targeted ground motions such that buildings designed according to these maps will have 1% chance of collapse in 50 years. These maps were developed by iterative risk calculation, wherein a generic building collapse fragility curve is convolved with the U.S. Geological Survey hazard curve until target risk criteria are met. Recent research shows that this current approach may be unconservative at locations where the tectonic environment is much different than that used to develop the generic fragility curve. This study illustrates how risk-targeted ground motions at selected sites would change if generic building fragility curve and hazard assessment were modified to account for seismic risk from subduction earthquakes and near-fault pulses. The paper also explores the difficulties in implementing these changes.

The Effects of Acute Cannabis Use on Nontraffic Injury Risk: Reviewing the Available Literature and Identifying Ways Forward

PubMed Central

Andreuccetti, Gabriel; Ye, Yu; Kang, Jaewook; Korcha, Rachael; Witbrodt, Jane A.; Carvalho, Heraclito B.; Cherpitel, Cheryl J.

2018-01-01

Recent evidence has indicated that cannabis use before driving is associated with a modest but increased risk for traffic-related injuries. However, the question of whether recent cannabis use is associated with a greater risk for other types of injuries remains unanswered. Aiming to understand better how acute cannabis use might affect the risk for all causes of injury, we have summarized the limited data available in the literature on the risk of non-traffic injuries associated with recent cannabis use. Very few studies were able to provide estimate risks for all injuries or injuries other than those related to road traffic injuries, with the limited evidence available showing mixed findings. The only significant risk found (in only one study) suggests an inverse association between all injuries and cannabis use. Study designs are limited, and the majority of studies have neither data on acute cannabis use among injured individuals nor a valid control group for estimating injury risk attributable to cannabis. In conclusion, studies of the association between cannabis and non-traffic injuries present several limitations, particularly regarding sampling strategies, injury risk assessment for different causes of injury, and a dose-response risk relationship with injury. Further studies, incorporating better design for different causes of injury and drug testing, are required to reach firmer conclusions on the association between cannabis use and non-traffic injury risk. PMID:29456273

The robust corrective action priority-an improved approach for selecting competing corrective actions in FMEA based on principle of robust design

NASA Astrophysics Data System (ADS)

Sutrisno, Agung; Gunawan, Indra; Vanany, Iwan

2017-11-01

In spite of being integral part in risk - based quality improvement effort, studies improving quality of selection of corrective action priority using FMEA technique are still limited in literature. If any, none is considering robustness and risk in selecting competing improvement initiatives. This study proposed a theoretical model to select risk - based competing corrective action by considering robustness and risk of competing corrective actions. We incorporated the principle of robust design in counting the preference score among corrective action candidates. Along with considering cost and benefit of competing corrective actions, we also incorporate the risk and robustness of corrective actions. An example is provided to represent the applicability of the proposed model.

The role of lymphadenectomy in endometrial cancer: was the ASTEC trial doomed by design and are we destined to repeat that mistake?

PubMed

Naumann, R Wendel

2012-07-01

This study examines the design of previous and future trials of lymph node dissection in endometrial cancer. Data from previous trials were used to construct a decision analysis modeling the risk of lymphatic spread and the effects of treatment on patients with endometrial cancer. This model was then applied to previous trials as well as other future trial designs that might be used to address this subject. Comparing the predicted and actual results in the ASTEC trial, the model closely mimics the survival results with and without lymph node dissection for the low and high risk groups. The model suggests a survival difference of less than 2% between the experimental and control arms of the ASTEC trial under all circumstances. Sensitivity analyses reveal that these conclusions are robust. Future trial designs were also modeled with hysterectomy only, hysterectomy with radiation in intermediate risk patients, and staging with radiation only with node positive patients. Predicted outcomes for these approaches yield survival rates of 88%, 90%, and 93% in clinical stage I patients who have a risk of pelvic node involvement of approximately 7%. These estimates were 78%, 82%, and 89% in intermediate risk patients who have a risk of nodal spread of approximately 15%. This model accurately predicts the outcome of previous trials and demonstrates that even if lymph node dissection was therapeutic, these trials would have been negative due to study design. Furthermore, future trial designs that are being considered would need to be conducted in high-intermediate risk patients to detect any difference. Copyright © 2012 Elsevier Inc. All rights reserved.

Case-Cohort Studies: Design and Applicability to Hand Surgery.

PubMed

Vojvodic, Miliana; Shafarenko, Mark; McCabe, Steven J

2018-04-24

Observational studies are common research strategies in hand surgery. The case-cohort design offers an efficient and resource-friendly method for risk assessment and outcomes analysis. Case-cohorts remain underrepresented in upper extremity research despite several practical and economic advantages over case-control studies. This report outlines the purpose, utility, and structure of the case-cohort design and offers a sample research question to demonstrate its value to risk estimation for adverse surgical outcomes. The application of well-designed case-cohort studies is advocated in an effort to improve the quality and quantity of observational research evidence in hand and upper extremity surgery. Copyright © 2018 American Society for Surgery of the Hand. Published by Elsevier Inc. All rights reserved.

Cast Coil Transformer Fire Susceptibility and Reliability Study

DTIC Science & Technology

1991-04-01

transformers reduce risk to the user compared to liquid-filled units, eliminate environmental impacts, are more efficient than most transformer designs, and...filled units, eliminate environmental impacts, arc more efficient than most transformer designs, and add minimal risk to the facility in a fire situation...add minimal risk to the facility in a fire situation. Cast coil transformers have a long record of operation and have proven to be reliable and

Effect of genetic testing for risk of type 2 diabetes mellitus on health behaviors and outcomes: study rationale, development and design.

PubMed

Cho, Alex H; Killeya-Jones, Ley A; O'Daniel, Julianne M; Kawamoto, Kensaku; Gallagher, Patrick; Haga, Susanne; Lucas, Joseph E; Trujillo, Gloria M; Joy, Scott V; Ginsburg, Geoffrey S

2012-01-18

Type 2 diabetes is a prevalent chronic condition globally that results in extensive morbidity, decreased quality of life, and increased health services utilization. Lifestyle changes can prevent the development of diabetes, but require patient engagement. Genetic risk testing might represent a new tool to increase patients' motivation for lifestyle changes. Here we describe the rationale, development, and design of a randomized controlled trial (RCT) assessing the clinical and personal utility of incorporating type 2 diabetes genetic risk testing into comprehensive diabetes risk assessments performed in a primary care setting. Patients are recruited in the laboratory waiting areas of two primary care clinics and enrolled into one of three study arms. Those interested in genetic risk testing are randomized to receive either a standard risk assessment (SRA) for type 2 diabetes incorporating conventional risk factors plus upfront disclosure of the results of genetic risk testing ("SRA+G" arm), or the SRA alone ("SRA" arm). Participants not interested in genetic risk testing will not receive the test, but will receive SRA (forming a third, "no-test" arm). Risk counseling is provided by clinic staff (not study staff external to the clinic). Fasting plasma glucose, insulin levels, body mass index (BMI), and waist circumference are measured at baseline and 12 months, as are patients' self-reported behavioral and emotional responses to diabetes risk information. Primary outcomes are changes in insulin resistance and BMI after 12 months; secondary outcomes include changes in diet patterns, physical activity, waist circumference, and perceived risk of developing diabetes. The utility, feasibility, and efficacy of providing patients with genetic risk information for common chronic diseases in primary care remain unknown. The study described here will help to establish whether providing type 2 diabetes genetic risk information in a primary care setting can help improve patients' clinical outcomes, risk perceptions, and/or their engagement in healthy behavior change. In addition, study design features such as the use of existing clinic personnel for risk counseling could inform the future development and implementation of care models for the use of individual genetic risk information in primary care. ClinicalTrials.gov: NCT00849563.

Commentary: How can family-based quasi-experimental designs and national registers be used to address confounding in risk factor studies of psychopathology? A reflection on Obel et al. (2016).

PubMed

Larsson, Henrik

2016-04-01

Standard observational studies have reported a robust correlation between maternal smoking during pregnancy and risk of ADHD in offspring. In the accompanying article, Obel et al. used sibling-comparisons to explore the extent to which unmeasured familial confounding explains this association. This commentary highlights three important implications of the study. At a general level, Obel et al. illustrates how (1) family-based quasi-experimental designs and (2) national registers can be used to address confounding in risk factor studies of psychopathology. At a more specific level, the study suggests that maternal smoking during pregnancy is probably not a causal risk factor for ADHD. © 2016 Association for Child and Adolescent Mental Health.

Serotonin reuptake inhibitors in pregnancy and the risk of major malformations: a systematic review.

PubMed

Bellantuono, Cesario; Migliarese, Giovanni; Gentile, Salvatore

2007-04-01

To review studies conducted to establish the risk of major congenital malformations in women exposed to serotonin reuptake inhibitors (SRIs) during the first trimester of pregnancy. A literature search [corrected] was conducted within PsycINFO [corrected] EMBASE, MEDLINE and Cochrane databases from 1966 to October 2006, to identify studies assessing the risk of major malformations in infants whose mother was taking SRIs (SSRIs and SNRIs) during the first trimester of pregnancy. Fifteen studies were selected for the analysis: seven adopted a prospective cohort design and seven a retrospective design, of these one was a case-control study. The reviewed studies suggest that exposure to fluoxetine, sertraline, citalopram and venlafaxine in early pregnancy is not associated with an increased risk of major congenital malformations. For paroxetine, recent data call for caution in prescribing such a drug in early pregnancy. For the other SRIs, the risk remains substantially undetermined, as data are so far scanty. Given this background, large prospective cohort studies are urgently needed to better assess the risk/benefit ratio of SRIs-treatment during pregnancy. Copyright 2007 John Wiley & Sons, Ltd.

DESIGNING STUDIES AND COLLECTING DATA USEFUL FOR CUMULATIVE RISK ASSESSMENT

EPA Science Inventory

DESIGNING STUDIES AND COLLECTING DATA USEFUL FOR CUMULATIVE RISK ASSESSMENT. J E Simmons1, C Gennings2, M Casey2, M J Plewa3, E D Wagner3, W H Carter, Jr.2, A McDonald1,Y M Sey1, L K Teuschler3 1NHEERL, ORD, U.S. EPA, RTP NC, USA; 2VCU, Richmond, VA, USA;3Univ. Illinois, Urba...

Mistreatment in Assisted Living Facilities: Complaints, Substantiations, and Risk Factors

ERIC Educational Resources Information Center

Phillips, Linda R.; Guo, Guifang

2011-01-01

Purpose of the Study: Use archived public data from Arizona to explore relationships among selected institutional and resident risk and situation-specific factors and complaints and substantiated allegations of various types of mistreatment in assisted living facilities (ALFs). Design and Methods: An exploratory/descriptive 2-group design was…

Evidence-based mapping of design heterogeneity prior to meta-analysis: a systematic review and evidence synthesis.

PubMed

Althuis, Michelle D; Weed, Douglas L; Frankenfeld, Cara L

2014-07-23

Assessment of design heterogeneity conducted prior to meta-analysis is infrequently reported; it is often presented post hoc to explain statistical heterogeneity. However, design heterogeneity determines the mix of included studies and how they are analyzed in a meta-analysis, which in turn can importantly influence the results. The goal of this work is to introduce ways to improve the assessment and reporting of design heterogeneity prior to statistical summarization of epidemiologic studies. In this paper, we use an assessment of sugar-sweetened beverages (SSB) and type 2 diabetes (T2D) as an example to show how a technique called 'evidence mapping' can be used to organize studies and evaluate design heterogeneity prior to meta-analysis.. Employing a systematic and reproducible approach, we evaluated the following elements across 11 selected cohort studies: variation in definitions of SSB, T2D, and co-variables, design features and population characteristics associated with specific definitions of SSB, and diversity in modeling strategies. Evidence mapping strategies effectively organized complex data and clearly depicted design heterogeneity. For example, across 11 studies of SSB and T2D, 7 measured diet only once (with 7 to 16 years of disease follow-up), 5 included primarily low SSB consumers, and 3 defined the study variable (SSB) as consumption of either sugar or artificially-sweetened beverages. This exercise also identified diversity in analysis strategies, such as adjustment for 11 to 17 co-variables and a large degree of fluctuation in SSB-T2D risk estimates depending on variables selected for multivariable models (2 to 95% change in the risk estimate from the age-adjusted model). Meta-analysis seeks to understand heterogeneity in addition to computing a summary risk estimate. This strategy effectively documents design heterogeneity, thus improving the practice of meta-analysis by aiding in: 1) protocol and analysis planning, 2) transparent reporting of differences in study designs, and 3) interpretation of pooled estimates. We recommend expanding the practice of meta-analysis reporting to include a table that summarizes design heterogeneity. This would provide readers with more evidence to interpret the summary risk estimates.

Evidence-based mapping of design heterogeneity prior to meta-analysis: a systematic review and evidence synthesis

PubMed Central

2014-01-01

Background Assessment of design heterogeneity conducted prior to meta-analysis is infrequently reported; it is often presented post hoc to explain statistical heterogeneity. However, design heterogeneity determines the mix of included studies and how they are analyzed in a meta-analysis, which in turn can importantly influence the results. The goal of this work is to introduce ways to improve the assessment and reporting of design heterogeneity prior to statistical summarization of epidemiologic studies. Methods In this paper, we use an assessment of sugar-sweetened beverages (SSB) and type 2 diabetes (T2D) as an example to show how a technique called ‘evidence mapping’ can be used to organize studies and evaluate design heterogeneity prior to meta-analysis.. Employing a systematic and reproducible approach, we evaluated the following elements across 11 selected cohort studies: variation in definitions of SSB, T2D, and co-variables, design features and population characteristics associated with specific definitions of SSB, and diversity in modeling strategies. Results Evidence mapping strategies effectively organized complex data and clearly depicted design heterogeneity. For example, across 11 studies of SSB and T2D, 7 measured diet only once (with 7 to 16 years of disease follow-up), 5 included primarily low SSB consumers, and 3 defined the study variable (SSB) as consumption of either sugar or artificially-sweetened beverages. This exercise also identified diversity in analysis strategies, such as adjustment for 11 to 17 co-variables and a large degree of fluctuation in SSB-T2D risk estimates depending on variables selected for multivariable models (2 to 95% change in the risk estimate from the age-adjusted model). Conclusions Meta-analysis seeks to understand heterogeneity in addition to computing a summary risk estimate. This strategy effectively documents design heterogeneity, thus improving the practice of meta-analysis by aiding in: 1) protocol and analysis planning, 2) transparent reporting of differences in study designs, and 3) interpretation of pooled estimates. We recommend expanding the practice of meta-analysis reporting to include a table that summarizes design heterogeneity. This would provide readers with more evidence to interpret the summary risk estimates. PMID:25055879

Bias correction of risk estimates in vaccine safety studies with rare adverse events using a self-controlled case series design.

PubMed

Zeng, Chan; Newcomer, Sophia R; Glanz, Jason M; Shoup, Jo Ann; Daley, Matthew F; Hambidge, Simon J; Xu, Stanley

2013-12-15

The self-controlled case series (SCCS) method is often used to examine the temporal association between vaccination and adverse events using only data from patients who experienced such events. Conditional Poisson regression models are used to estimate incidence rate ratios, and these models perform well with large or medium-sized case samples. However, in some vaccine safety studies, the adverse events studied are rare and the maximum likelihood estimates may be biased. Several bias correction methods have been examined in case-control studies using conditional logistic regression, but none of these methods have been evaluated in studies using the SCCS design. In this study, we used simulations to evaluate 2 bias correction approaches-the Firth penalized maximum likelihood method and Cordeiro and McCullagh's bias reduction after maximum likelihood estimation-with small sample sizes in studies using the SCCS design. The simulations showed that the bias under the SCCS design with a small number of cases can be large and is also sensitive to a short risk period. The Firth correction method provides finite and less biased estimates than the maximum likelihood method and Cordeiro and McCullagh's method. However, limitations still exist when the risk period in the SCCS design is short relative to the entire observation period.

The impact of cigarette pack design, descriptors, and warning labels on risk perception in the U.S.

PubMed

Bansal-Travers, Maansi; Hammond, David; Smith, Philip; Cummings, K Michael

2011-06-01

In the U.S., limited evidence exists on the impact of colors and brand imagery used in cigarette pack design. This study examined the impact of pack design, product descriptors, and health warnings on risk perception and brand appeal. A cross-sectional mall-intercept study was conducted with 197 adult smokers and 200 nonsmokers in Buffalo NY from June to July 2009 (data analysis from July 2009 to December 2010). Participants were shown 12 sets of packs randomly; each set varied by a particular design feature (color, descriptor) or warning label style (text versus graphic, size, attribution, message framing). Packs were rated on criteria including risk perceptions, quit motivation, and purchase interest. Participants selected larger, pictorial, and loss-framed warning labels as more likely to attract attention, encourage thoughts about health risks, motivate quitting, and be most effective. Participants were more likely to select packs with lighter color shading and descriptors such as light, silver, and smooth as delivering less tar, smoother taste, and lower health risk, compared to darker-shaded or full-flavor packs. Additionally, participants were more likely to select the branded compared to plain white pack when asked which delivered the most tar, smoothest taste, was more attractive, appealed to youth aged <18 years, and contained cigarettes of better quality. The findings support larger, graphic health warnings that convey loss-framed messages as most effective in communicating health risks to U.S. adults. The results also indicate that color and product descriptors are associated with false beliefs about risks. Plain packaging may reduce many of the erroneous misperceptions of risk communicated through pack design features. Copyright © 2011 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.

The Impact of Cigarette Pack Design, Descriptors, and Warning Labels on Risk Perception in the U.S

PubMed Central

Bansal-Travers, Maansi; Hammond, David; Smith, Philip; Cummings, K. Michael

2011-01-01

Background In the U.S., limited evidence exists on the impact of colors and brand imagery used in cigarette pack design. Purpose This study examined the impact of pack design, product descriptors, and health warnings on risk perception and brand appeal. Methods A cross-sectional mall-intercept study was conducted with 197 adult smokers and 200 nonsmokers in Buffalo, NY from June to July 2009 (data analysis from July 2009 to December 2010). Participants were shown 12 sets of packs randomly; each set varied by a particular design feature (color, descriptor) or warning label style (text vs graphic, size, attribution, message framing). Packs were rated on criteria including risk perceptions, quit motivation, and purchase interest. Results Participants selected larger, pictorial, and loss-framed warning labels as more likely to attract attention, encourage thoughts about health risks, motivate quitting, and most effective. Participants were more likely to select packs with lighter color shading and descriptors such as light, silver, and smooth as delivering less tar, smoother taste, and lower health risk, compared to darker-shaded or full flavor packs. Additionally, participants were more likely to select the branded compared to plain white pack when asked which delivered the most tar, smoothest taste, was more attractive, appealed to youth aged <18 years, and contained cigarettes of better quality. Conclusions The findings support larger, graphic health warnings that convey loss-framed messages as most effective in communicating health risks to U.S. adults. The results also indicate that color and product descriptors are associated with false beliefs about risks. Plain packaging may reduce many of the erroneous misperceptions of risk communicated through pack design features. PMID:21565661

[The choice of the type of design in the clinical investigation studies. Case and control studies].

PubMed

Posada de la Paz, M

2004-09-01

Case-control studies are appropriate designs in neurology sciences to search for risk factors that have already occurred in a group of patients. In them, the subjects are selected on the basis of whether they have the disease or not and then they are compared in regards to the risk factor or prognosis investigated. These sorts of designs can be performed in a shorter and cheaper way than the regular cohort studies. They are appropriate for the evaluation of rare diseases and can examine multiple etiological factors for a single disease. On the contrary, they are not so efficient when rare exposures are involved. Incidence rates in exposed and non-exposed subjects cannot be calculated and on some occasions, the timing between exposure and outcome can be very difficult to establish. The Odds Ratio and its confident intervals is the measurement used for estimating the risk strength in this design. The clinical neurologist should be familiar with these terms, given the frequency of case-control studies described in neurology science literature, and should know their principal advantages and limitations.

[Eco-epidemiology: towards epidemiology of complexity].

PubMed

Bizouarn, Philippe

2016-05-01

In order to solve public health problems posed by the epidemiology of risk factors centered on the individual and neglecting the causal processes linking the risk factors with the health outcomes, Mervyn Susser proposed a multilevel epidemiology called eco-epidemiology, addressing the interdependence of individuals and their connection with molecular, individual, societal, environmental levels of organization participating in the causal disease processes. The aim of this epidemiology is to integrate more than a level of organization in design, analysis and interpretation of health problems. After presenting the main criticisms of risk-factor epidemiology focused on the individual, we will try to show how eco-epidemiology and its development could help to understand the need for a broader and integrative epidemiology, in which studies designed to identify risk factors would be balanced by studies designed to answer other questions equally vital to public health. © 2016 médecine/sciences – Inserm.

PRA (Probabilistic Risk Assessments) Participation versus Validation

NASA Technical Reports Server (NTRS)

DeMott, Diana; Banke, Richard

2013-01-01

Probabilistic Risk Assessments (PRAs) are performed for projects or programs where the consequences of failure are highly undesirable. PRAs primarily address the level of risk those projects or programs posed during operations. PRAs are often developed after the design has been completed. Design and operational details used to develop models include approved and accepted design information regarding equipment, components, systems and failure data. This methodology basically validates the risk parameters of the project or system design. For high risk or high dollar projects, using PRA methodologies during the design process provides new opportunities to influence the design early in the project life cycle to identify, eliminate or mitigate potential risks. Identifying risk drivers before the design has been set allows the design engineers to understand the inherent risk of their current design and consider potential risk mitigation changes. This can become an iterative process where the PRA model can be used to determine if the mitigation technique is effective in reducing risk. This can result in more efficient and cost effective design changes. PRA methodology can be used to assess the risk of design alternatives and can demonstrate how major design changes or program modifications impact the overall program or project risk. PRA has been used for the last two decades to validate risk predictions and acceptability. Providing risk information which can positively influence final system and equipment design the PRA tool can also participate in design development, providing a safe and cost effective product.

Conceptual design study of Fusion Experimental Reactor (FY86 FER): Safety

NASA Astrophysics Data System (ADS)

Seki, Yasushi; Iida, Hiromasa; Honda, Tsutomu

1987-08-01

This report describes the study on safety for FER (Fusion Experimental Reactor) which has been designed as a next step machine to the JT-60. Though the final purpose of this study is to have an image of design base accident, maximum credible accident and to assess their risk or probability, etc., as FER plant system, the emphasis of this years study is placed on fuel-gas circulation system where the tritium inventory is maximum. The report consists of two chapters. The first chapter summarizes the FER system and describes FMEA (Failure Mode and Effect Analysis) and related accident progression sequence for FER plant system as a whole. The second chapter of this report is focused on fuel-gas circulation system including purification, isotope separation and storage. Probability of risk is assessed by the probabilistic risk analysis (PRA) procedure based on FMEA, ETA and FTA.

Towards Risk Based Design for NASA's Missions

NASA Technical Reports Server (NTRS)

Tumer, Irem Y.; Barrientos, Francesca; Meshkat, Leila

2004-01-01

This paper describes the concept of Risk Based Design in the context of NASA s low volume, high cost missions. The concept of accounting for risk in the design lifecycle has been discussed and proposed under several research topics, including reliability, risk analysis, optimization, uncertainty, decision-based design, and robust design. This work aims to identify and develop methods to enable and automate a means to characterize and optimize risk, and use risk as a tradeable resource to make robust and reliable decisions, in the context of the uncertain and ambiguous stage of early conceptual design. This paper first presents a survey of the related topics explored in the design research community as they relate to risk based design. Then, a summary of the topics from the NASA-led Risk Colloquium is presented, followed by current efforts within NASA to account for risk in early design. Finally, a list of "risk elements", identified for early-phase conceptual design at NASA, is presented. The purpose is to lay the foundation and develop a roadmap for future work and collaborations for research to eliminate and mitigate these risk elements in early phase design.

The exposure-crossover design is a new method for studying sustained changes in recurrent events.

PubMed

Redelmeier, Donald A

2013-09-01

To introduce a new design that explores how an acute exposure might lead to a sustained change in the risk of a recurrent outcome. The exposure-crossover design uses self-matching to control within-person confounding due to genetics, personality, and all other stable patient characteristics. The design is demonstrated using population-based individual-level health data from Ontario, Canada, for three separate medical conditions (n > 100,000 for each) related to the risk of a motor vehicle crash (total outcomes, >2,000 for each). The exposure-crossover design yields numerical risk estimates during the baseline interval before an intervention, the induction interval immediately ahead of the intervention, and the subsequent interval after the intervention. Accompanying graphs summarize results, provide an intuitive display to readers, and show risk comparisons (absolute and relative). Self-matching increases statistical efficiency, reduces selection bias, and yields quantitative analyses. The design has potential limitations related to confounding, artifacts, pragmatics, survivor bias, statistical models, potential misunderstandings, and serendipity. The exposure-crossover design may help in exploring selected questions in epidemiology science. Copyright © 2013 Elsevier Inc. All rights reserved.

Teaching Risk Analysis in an Aircraft Gas Turbine Engine Design Capstone Course

DTIC Science & Technology

2016-01-01

American Institute of Aeronautics and Astronautics 1 Teaching Risk Analysis in an Aircraft Gas Turbine Engine Design Capstone Course...development costs, engine production costs, and scheduling (Byerley A. R., 2013) as well as the linkage between turbine inlet temperature, blade cooling...analysis SE majors have studied and how this is linked to the specific issues they must face in aircraft gas turbine engine design. Aeronautical and

Is protective equipment useful in preventing concussion? A systematic review of the literature.

PubMed

Benson, B W; Hamilton, G M; Meeuwisse, W H; McCrory, P; Dvorak, J

2009-05-01

To determine if there is evidence that equipment use reduces sport concussion risk and/or severity. 12 electronic databases were searched using a combination of Medical Subject Headings and text words to identify relevant articles. Specific inclusion and exclusion criteria were used to select studies for review. Data extracted included design, study population, exposure/outcome measures and results. The quality of evidence was assessed based on epidemiologic criteria regarding internal and external validity (ie, strength of design, sample size/power calculation, selection bias, misclassification bias, control of potential confounding and effect modification). In total, 51 studies were selected for review. A comparison between studies was difficult due to the variability in research designs, definition of concussion, mouthguard/helmet/headgear/face shield types, measurements used to assess exposure and outcomes, and variety of sports assessed. The majority of studies were observational, with 23 analytical epidemiologic designs related to the subject area. Selection bias was a concern in the reviewed studies, as was the lack of measurement and control for potentially confounding variables. There is evidence that helmet use reduces head injury risk in skiing, snowboarding and bicycling, but the effect on concussion risk is inconclusive. No strong evidence exists for the use of mouthguards or face shields to reduce concussion risk. Evidence is provided to suggest that full facial protection in ice hockey may reduce concussion severity, as measured by time loss from competition.

The effect of an Internet-based intervention designed to reduce HIV/AIDS sexual risk among Mexican adolescents.

PubMed

Castillo-Arcos, Lubia Del Carmen; Benavides-Torres, Raquel Alicia; López-Rosales, Fuensanta; Onofre-Rodríguez, Dora Julia; Valdez-Montero, Carolina; Maas-Góngora, Lucely

2016-01-01

The purpose of the study was to evaluate the effect of an Internet-based intervention to reduce sexual risk behaviors and increase resilience to sexual risk behaviors among Mexican adolescents, a key HIV/AIDS risk group. The study had a quasi-experimental design with single-stage cluster sampling. Participants ages 14-17 were stratified by gender and randomly assigned to either receive intervention "Connect" (which included face-to-face and Internet-based sessions designed to reduce sexual risk behaviors and increase resilience to sexual risk) or control (a general educational video on reducing health risks). A total of 9 survey instruments were administered online through SurveyMonkey pre- and post-intervention to assess changes in sexual risk and protective factors as well as two outcomes of interest: risky sexual behaviors and resilience. Pearson correlation assessed instrument reliability while multivariable linear regression models assessed two study hypotheses: (1) the effect of the intervention on sexual behavior and resilience is mediated by adolescent age, gender, and sexual experience and (2) risk and protective factors are mediators between the intervention and sexual behavior. The sample was composed of 193 adolescents between 14 and 17 years old (n = 96 in the control group and n = 97 in the experimental group). Survey instruments were reliable. Age was associated with pre-to-post test changes in sexual resilience (β = -6.10, p = .019), which partially mediated the effect of the intervention on sexual resilience (β = 5.70, p = .034). Social support was associated with pre-to-post test changes in risky sexual behavior (β = -0.17, p = .039). Intervention "Connect" was independently associated with improved self-reported resilience to risky sexual behaviors, though not with a reduction in those behaviors in multivariate analyses. This is the first Internet-based intervention designed to reduce HIV/AIDS sexual risk among Mexican adolescents.

Methodology for safety optimization of highway cross-sections for horizontal curves with restricted sight distance.

PubMed

Ibrahim, Shewkar E; Sayed, Tarek; Ismail, Karim

2012-11-01

Several earlier studies have noted the shortcomings with existing geometric design guides which provide deterministic standards. In these standards the safety margin of the design output is generally unknown and there is little knowledge of the safety implications of deviating from the standards. To mitigate these shortcomings, probabilistic geometric design has been advocated where reliability analysis can be used to account for the uncertainty in the design parameters and to provide a mechanism for risk measurement to evaluate the safety impact of deviations from design standards. This paper applies reliability analysis for optimizing the safety of highway cross-sections. The paper presents an original methodology to select a suitable combination of cross-section elements with restricted sight distance to result in reduced collisions and consistent risk levels. The purpose of this optimization method is to provide designers with a proactive approach to the design of cross-section elements in order to (i) minimize the risk associated with restricted sight distance, (ii) balance the risk across the two carriageways of the highway, and (iii) reduce the expected collision frequency. A case study involving nine cross-sections that are parts of two major highway developments in British Columbia, Canada, was presented. The results showed that an additional reduction in collisions can be realized by incorporating the reliability component, P(nc) (denoting the probability of non-compliance), in the optimization process. The proposed approach results in reduced and consistent risk levels for both travel directions in addition to further collision reductions. Copyright © 2012 Elsevier Ltd. All rights reserved.

Design definition study of a NASA/Navy lift/cruise fan technology V/STOL airplane: Risk assessment addendum to the final report

NASA Technical Reports Server (NTRS)

Zabinsky, J. M.; Burnham, R. W.; Flora, C. C.; Gotlieb, P.; Grande, D. L.; Gunnarson, D. W.; Howard, W. M.; Hunt, D.; Jakubowski, G. W.; Johnson, P. E.

1975-01-01

An assessment of risk, in terms of delivery delays, cost overrun, and performance achievement, associated with the V/STOL technology airplane is presented. The risk is discussed in terms of weight, structure, aerodynamics, propulsion, mechanical drive, and flight controls. The analysis ensures that risks associated with the design and development of the airplane will be eliminated in the course of the program and a useful technology airplane that meets the predicted cost, schedule, and performance can be produced.

Rotor systems research aircraft predesign study. Volume 3: Predesign report

NASA Technical Reports Server (NTRS)

Schmidt, S. A.; Linden, A. W.

1972-01-01

The features of two aircraft designs were selected to be included in the single RSRA configuration. A study was conducted for further preliminary design and a more detailed analysis of development plans and costs. An analysis was also made of foreseeable technical problems and risks, identification of parallel research which would reduce risks and/or add to the basic capability of the aircraft, and a draft aircraft specification.

Validating the Vocabulary Levels Test with Fourth and Fifth Graders to Identify Students At-Risk in Vocabulary Development Using a Quasiexperimental Single Group Design

ERIC Educational Resources Information Center

Dunn, Suzanna

2012-01-01

This quasiexperimental single group design study investigated the validity of the Vocabulary Levels Test (VLT) to identify fourth and fifth grade students who are at-risk in vocabulary development. The subjects of the study were 88 fourth and fifth grade students at one elementary school in Washington State. The Group Reading Assessment and…

Practice-Based Research Network Infrastructure Design for Institutional Review Board Risk Assessment and Generalizability of Clinical Results.

PubMed

Curro, Frederick; Thompson, Van P; Naftolin, Frederick; Grill, Ashley; Vena, Don; Terracio, Louis; Hashimoto, Mariko; Buchholz, Matthew; McKinstry, Andrea; Cannon, Diane; Alfano, Vincent; Gooden, Thalia; Vernillo, Anthony; Czeisler, Elan

2013-01-01

Data from clinical studies generated by Practice Based Research Networks should be generalizable to the profession. For nationally representative data a broad recruitment of practitioners may pose added risks to IRB's. Infrastructure must assure data integrity while minimizing risk to assure that the clinical results are generalizable. The PEARL Network is an interdisciplinary dental/medical PBRN conducting a broad range of clinical studies. The infrastructure is designed to support the principles of Good Clinical Practice (GCP) and create a data audit trail to ensure data integrity for generalizability. As the PBRN concept becomes of greater interest, membership may expand beyond the local community, and the issue of geography versus risk management becomes of concern to the IRB. The PEARL Network describes how it resolves many of the issues related to recruiting on a National basis while maintaining study compliance to ensure patient safety and minimize risk to the IRB.

Mars Design Reference Architecture 5.0 Study: Executive Summary

NASA Technical Reports Server (NTRS)

Drake, Bret G.

2008-01-01

The NASA Mars Design Reference Architecture 5.0 Study seeks to update its long term goals and objective for human exploration missions; flight and surface systems for human missions and supporting infrastructure; operational concept for human and robotic exploration of Mars; key challenges including risk and cost drivers; and, its development schedule options. It additionally seeks to assess strategic linkages between lunar and Mars strategies and develop and understanding of methods for reducing the cost/risk of human Mars missions through investment in research, technology development, and synergy with other exploration plans. Recommendations are made regarding conjunction class (long-stay) missions which are seen as providing the best balance of cost, risk, and performance. Additionally, this study reviews entry, descent, and landing challenges; in-space transportation systems; launch vehicle and Orion assessments; risk and risk mitigation; key driving requirements and challenges; and, lunar linkages.

Health risk behaviours amongst school adolescents: protocol for a mixed methods study.

PubMed

El Achhab, Youness; El Ammari, Abdelghaffar; El Kazdouh, Hicham; Najdi, Adil; Berraho, Mohamed; Tachfouti, Nabil; Lamri, Driss; El Fakir, Samira; Nejjari, Chakib

2016-11-29

Determining risky behaviours of adolescents provides valuable information for designing appropriate intervention programmes for advancing adolescent's health. However, these behaviours are not fully addressed by researchers in a comprehensive approach. We report the protocol of a mixed methods study designed to investigate the health risk behaviours of Moroccan adolescents with the goal of identifying suitable strategies to address their health concerns. We used a sequential two-phase explanatory mixed method study design. The approach begins with the collection of quantitative data, followed by the collection of qualitative data to explain and enrich the quantitative findings. In the first phase, the global school-based student health survey (GSHS) was administered to 800 students who were between 14 and 19 years of age. The second phase engaged adolescents, parents and teachers in focus groups and assessed education documents to explore the level of coverage of health education in the programme learnt in the middle school. To obtain opinions about strategies to reduce Moroccan adolescents' health risk behaviours, a nominal group technique will be used. The findings of this mixed methods sequential explanatory study provide insights into the risk behaviours that need to be considered if intervention programmes and preventive strategies are to be designed to promote adolescent's health in the Moroccan school.

Methodology for conceptual remote sensing spacecraft technology: insertion analysis balancing performance, cost, and risk

NASA Astrophysics Data System (ADS)

Bearden, David A.; Duclos, Donald P.; Barrera, Mark J.; Mosher, Todd J.; Lao, Norman Y.

1997-12-01

Emerging technologies and micro-instrumentation are changing the way remote sensing spacecraft missions are developed and implemented. Government agencies responsible for procuring space systems are increasingly requesting analyses to estimate cost, performance and design impacts of advanced technology insertion for both state-of-the-art systems as well as systems to be built 5 to 10 years in the future. Numerous spacecraft technology development programs are being sponsored by Department of Defense (DoD) and National Aeronautics and Space Administration (NASA) agencies with the goal of enhancing spacecraft performance, reducing mass, and reducing cost. However, it is often the case that technology studies, in the interest of maximizing subsystem-level performance and/or mass reduction, do not anticipate synergistic system-level effects. Furthermore, even though technical risks are often identified as one of the largest cost drivers for space systems, many cost/design processes and models ignore effects of cost risk in the interest of quick estimates. To address these issues, the Aerospace Corporation developed a concept analysis methodology and associated software tools. These tools, collectively referred to as the concept analysis and design evaluation toolkit (CADET), facilitate system architecture studies and space system conceptual designs focusing on design heritage, technology selection, and associated effects on cost, risk and performance at the system and subsystem level. CADET allows: (1) quick response to technical design and cost questions; (2) assessment of the cost and performance impacts of existing and new designs/technologies; and (3) estimation of cost uncertainties and risks. These capabilities aid mission designers in determining the configuration of remote sensing missions that meet essential requirements in a cost- effective manner. This paper discuses the development of CADET modules and their application to several remote sensing satellite mission concepts.

The Littoral Combat Ship: Is the US Navy Assuming Too Much Risk?

DTIC Science & Technology

2006-06-16

whereas the General Dynamics design will focus on an all- aluminum trimaran hull. Additional study of the pros and cons based on these two designs and......also important to understand that not all risk is bad. The SWOT analysis, which looks at the strengths, weaknesses, opportunities, and threats

Coordinating resources for prospective medication risk management of older home care clients in primary care: procedure development and RCT study design for demonstrating its effectiveness.

PubMed

Toivo, Terhi; Dimitrow, Maarit; Puustinen, Juha; Savela, Eeva; Pelkonen, Katariina; Kiuru, Valtteri; Suominen, Tuula; Kinnunen, Sirkka; Uunimäki, Mira; Kivelä, Sirkka-Liisa; Leikola, Saija; Airaksinen, Marja

2018-03-16

The magnitude of safety risks related to medications of the older adults has been evidenced by numerous studies, but less is known of how to manage and prevent these risks in different health care settings. The aim of this study was to coordinate resources for prospective medication risk management of home care clients ≥ 65 years in primary care and to develop a study design for demonstrating effectiveness of the procedure. Health care units involved in the study are from primary care in Lohja, Southern Finland: home care (191 consented clients), the public healthcare center, and a private community pharmacy. System based risk management theory and action research method was applied to construct the collaborative procedure utilizing each profession's existing resources in medication risk management of older home care clients. An inventory of clinical measures in usual clinical practice and systematic review of rigorous study designs was utilized in effectiveness study design. The new coordinated medication management model (CoMM) has the following 5 stages: 1) practical nurses are trained to identify clinically significant drug-related problems (DRPs) during home visits and report those to the clinical pharmacist. Clinical pharmacist prepares the cases for 2) an interprofessional triage meeting (50-70 cases/meeting of 2 h) where decisions are made on further action, e.g., more detailed medication reviews, 3) community pharmacists conduct necessary medication reviews and each patients' physician makes final decisions on medication changes needed. The final stages concern 4) implementation and 5) follow-up of medication changes. Randomized controlled trial (RCT) was developed to demonstrate the effectiveness of the procedure. The developed procedure is feasible for screening and reviewing medications of a high number of older home care clients to identify clients with severe DRPs and provide interventions to solve them utilizing existing primary care resources. The study is registered in the Clinical Trials.gov ( NCT02545257 ). Registration date September 9 2015.

Implied preference for seismic design level and earthquake insurance.

PubMed

Goda, K; Hong, H P

2008-04-01

Seismic risk can be reduced by implementing newly developed seismic provisions in design codes. Furthermore, financial protection or enhanced utility and happiness for stakeholders could be gained through the purchase of earthquake insurance. If this is not so, there would be no market for such insurance. However, perceived benefit associated with insurance is not universally shared by stakeholders partly due to their diverse risk attitudes. This study investigates the implied seismic design preference with insurance options for decisionmakers of bounded rationality whose preferences could be adequately represented by the cumulative prospect theory (CPT). The investigation is focused on assessing the sensitivity of the implied seismic design preference with insurance options to model parameters of the CPT and to fair and unfair insurance arrangements. Numerical results suggest that human cognitive limitation and risk perception can affect the implied seismic design preference by the CPT significantly. The mandatory purchase of fair insurance will lead the implied seismic design preference to the optimum design level that is dictated by the minimum expected lifecycle cost rule. Unfair insurance decreases the expected gain as well as its associated variability, which is preferred by risk-averse decisionmakers. The obtained results of the implied preference for the combination of the seismic design level and insurance option suggest that property owners, financial institutions, and municipalities can take advantage of affordable insurance to establish successful seismic risk management strategies.

ROBIS: A new tool to assess risk of bias in systematic reviews was developed

PubMed Central

Whiting, Penny; Savović, Jelena; Higgins, Julian P.T.; Caldwell, Deborah M.; Reeves, Barnaby C.; Shea, Beverley; Davies, Philippa; Kleijnen, Jos; Churchill, Rachel

2016-01-01

Objective To develop ROBIS, a new tool for assessing the risk of bias in systematic reviews (rather than in primary studies). Study Design and Setting We used four-stage approach to develop ROBIS: define the scope, review the evidence base, hold a face-to-face meeting, and refine the tool through piloting. Results ROBIS is currently aimed at four broad categories of reviews mainly within health care settings: interventions, diagnosis, prognosis, and etiology. The target audience of ROBIS is primarily guideline developers, authors of overviews of systematic reviews (“reviews of reviews”), and review authors who might want to assess or avoid risk of bias in their reviews. The tool is completed in three phases: (1) assess relevance (optional), (2) identify concerns with the review process, and (3) judge risk of bias. Phase 2 covers four domains through which bias may be introduced into a systematic review: study eligibility criteria; identification and selection of studies; data collection and study appraisal; and synthesis and findings. Phase 3 assesses the overall risk of bias in the interpretation of review findings and whether this considered limitations identified in any of the phase 2 domains. Signaling questions are included to help judge concerns with the review process (phase 2) and the overall risk of bias in the review (phase 3); these questions flag aspects of review design related to the potential for bias and aim to help assessors judge risk of bias in the review process, results, and conclusions. Conclusions ROBIS is the first rigorously developed tool designed specifically to assess the risk of bias in systematic reviews. PMID:26092286

Implementation of the NHLBI Integrated Guidelines for Cardiovascular Health and Risk Reduction in Children and Adolescents: Rationale and Study Design for Young Hearts, Strong Starts, a Cluster-Randomized Trial Targeting Body Mass Index, Blood Pressure, and Tobacco

PubMed Central

LaBresh, Kenneth A.; Lazorick, Suzanne; Ariza, Adolfo J.; Furberg, Robert D.; Whetstone, Lauren; Hobbs, Connie; de Jesus, Janet; Bender, Randall H.; Salinas, Ilse G.; Binns, Helen J.

2014-01-01

Background Cardiovascular disease (CVD) and the underlying atherosclerosis begin in childhood, and their presence and intensity are related to known cardiovascular disease risk factors. Attention to risk factor control in childhood has the potential to reduce subsequent risk of CVD. Objective The Young Hearts Strong Starts Study was designed to test strategies facilitating adoption of the National, Heart, Lung and Blood Institute supported Integrated Guidelines for Cardiovascular Health and Risk Reduction in Children and Adolescents. This study compares guideline-based quality measures for body mass index, blood pressure, and tobacco using two strategies: a multifaceted, practice-directed intervention versus standard dissemination. Study Design Two primary care research networks recruited practices and provided support for the intervention and outcome evaluations. Individual practices were randomly assigned to the intervention or control groups using a cluster randomized design based on network affiliation, number of clinicians per practice, urban versus nonurban location, and practice type. The units of observation are individual children because measure adherence is abstracted from individual patient’s medical records. The units of randomization are physician practices. This results in a multilevel design in which patients are nested within practices. The intervention practices received toolkits and supported guideline implementation including academic detailing, an ongoing e-learning group. This project is aligned with the American Board of Pediatrics Maintenance of Certification requirements including monthly physician self-abstraction, webinars, and other elements of the trial. Significance This trial will provide an opportunity to demonstrate tools and strategies to enhance CV prevention in children by guideline-based interventions. PMID:24295879

Recommendations for assessing the risk of bias in systematic reviews of health-care interventions.

PubMed

Viswanathan, Meera; Patnode, Carrie D; Berkman, Nancy D; Bass, Eric B; Chang, Stephanie; Hartling, Lisa; Murad, M Hassan; Treadwell, Jonathan R; Kane, Robert L

2018-05-01

Risk-of-bias assessment is a central component of systematic reviews, but little conclusive empirical evidence exists on the validity of such assessments. In the context of such uncertainty, we present pragmatic recommendations that promote transparency and reproducibility in processes, address methodological advances in the risk-of-bias assessment, and can be applied consistently across review topics. Epidemiological study design principles; available empirical evidence, risk-of-bias tools, and guidance; and workgroup consensus. We developed recommendations for assessing the risk of bias of studies of health-care interventions specific to framing the focus and scope of risk-of-bias assessment; selecting the risk-of-bias categories; choosing assessment instruments; and conducting, analyzing, and presenting results of risk-of-bias assessments. Key recommendations include transparency and reproducibility of judgments, separating risk of bias from other constructs such as applicability and precision, and evaluating the risk of bias per outcome. We recommend against certain past practices, such as focusing on reporting quality, relying solely on study design or numerical quality scores, and automatically downgrading for industry sponsorship. Risk-of-bias assessment remains a challenging but essential step in systematic reviews. We presented standards to promote transparency of judgments. Copyright © 2017 Elsevier Inc. All rights reserved.

A Systematic Approach of Employing Quality by Design Principles: Risk Assessment and Design of Experiments to Demonstrate Process Understanding and Identify the Critical Process Parameters for Coating of the Ethylcellulose Pseudolatex Dispersion Using Non-Conventional Fluid Bed Process.

PubMed

Kothari, Bhaveshkumar H; Fahmy, Raafat; Claycamp, H Gregg; Moore, Christine M V; Chatterjee, Sharmista; Hoag, Stephen W

2017-05-01

The goal of this study was to utilize risk assessment techniques and statistical design of experiments (DoE) to gain process understanding and to identify critical process parameters for the manufacture of controlled release multiparticulate beads using a novel disk-jet fluid bed technology. The material attributes and process parameters were systematically assessed using the Ishikawa fish bone diagram and failure mode and effect analysis (FMEA) risk assessment methods. The high risk attributes identified by the FMEA analysis were further explored using resolution V fractional factorial design. To gain an understanding of the processing parameters, a resolution V fractional factorial study was conducted. Using knowledge gained from the resolution V study, a resolution IV fractional factorial study was conducted; the purpose of this IV study was to identify the critical process parameters (CPP) that impact the critical quality attributes and understand the influence of these parameters on film formation. For both studies, the microclimate, atomization pressure, inlet air volume, product temperature (during spraying and curing), curing time, and percent solids in the coating solutions were studied. The responses evaluated were percent agglomeration, percent fines, percent yield, bead aspect ratio, median particle size diameter (d50), assay, and drug release rate. Pyrobuttons® were used to record real-time temperature and humidity changes in the fluid bed. The risk assessment methods and process analytical tools helped to understand the novel disk-jet technology and to systematically develop models of the coating process parameters like process efficiency and the extent of curing during the coating process.

Antipsychotic drugs and risk of type 2 diabetes: an evidence-based approach.

PubMed

Bellantuono, Cesario; Tentoni, Luigi; Donda, Pietro

2004-12-01

To review studies conducted to evaluate the risk of type 2 diabetes in patients treated with different antipsychotic drugs (AP). a MEDLINE search (January 1985-February 2003) was conducted to establish the potential relationship between the exposure to AP (conventional and second generation) and the development of type 2 diabetes. Studies were classified according to their experimental design as prospective and retrospective (incidence and prevalence based). Twenty-one studies were selected: nine prospective and eleven retrospective. Patients with schizophrenia treated with different AP have an increased risk of developing type 2 diabetes compared with the general population. The data so far available, however, do not establish whether the increasing risk of developing diabetes is a function of the schizophrenia itself or is induced by the antipsychotic treatment. A number of methodological flaws in the study design and data collection do not allow conclusions to be drawn on the risk between patients treated with conventional drugs versus those treated with new ones. 2004 John Wiley & Sons, Ltd.

Implementing an Early Intervention Program for Residential Students Who Present with Suicide Risk: A Case Study

ERIC Educational Resources Information Center

Rivero, Estela M.; Cimini, M. Dolores; Bernier, Joseph E.; Stanley, Judith A.; Murray, Andrea D.; Anderson, Drew A.; Wright, Heidi R.

2014-01-01

Objective: This case study examined the effects of an early intervention program designed to respond to residential college students demonstrating risk for suicide. Participants: Participants were 108 undergraduates at a large northeastern public university referred to an early intervention program subsequent to presenting with risk factors for…

ASSESSING WATERBORNE RISKS: AN INTRODUCTION

EPA Science Inventory

Information in this article can help readers evaluate the results of epidemiologic studies of

waterborne disease risks. It is important that readers understand the various epidemiologic study

designs, their strengths and limitations, and potential biases. Terminolog...

Risk factors for pressure ulcer development in critically Ill patients: a conceptual model to guide research.

PubMed

Benoit, Richard; Mion, Lorraine

2012-08-01

This paper presents a proposed conceptual model to guide research on pressure ulcer risk in critically ill patients, who are at high risk for pressure ulcer development. However, no conceptual model exists that guides risk assessment in this population. Results from a review of prospective studies were evaluated for design quality and level of statistical reporting. Multivariate findings from studies having high or medium design quality by the National Institute of Health and Clinical Excellence standards were conceptually grouped. The conceptual groupings were integrated into Braden and Bergstrom's (Braden and Bergstrom [1987] Rehabilitation Nursing, 12, 8-12, 16) conceptual model, retaining their original constructs and augmenting their concept of intrinsic factors for tissue tolerance. The model could enhance consistency in research on pressure ulcer risk factors. Copyright © 2012 Wiley Periodicals, Inc.

Drug and alcohol crash risk : a case-control study.

DOT National Transportation Integrated Search

2016-12-01

This study used a case-control design to estimate the risk of crashes involving drivers using drugs, alcohol or both. Data was collected in Virginia Beach, Virginia, for 20 months. The study obtained biological measures on more than 3,000 crash...

Design of Stripping Columns Applied to Drinking Water to Minimize Carcinogenic Risk from Trihalomethanes (THMs)

PubMed Central

Canosa, Joel

2018-01-01

The aim of this study is the application of a software tool to the design of stripping columns to calculate the removal of trihalomethanes (THMs) from drinking water. The tool also allows calculating the rough capital cost of the column and the decrease in carcinogenic risk indeces associated with the elimination of THMs and, thus, the investment to save a human life. The design of stripping columns includes the determination, among other factors, of the height (HOG), the theoretical number of plates (NOG), and the section (S) of the columns based on the study of pressure drop. These results have been compared with THM stripping literature values, showing that simulation is sufficiently conservative. Three case studies were chosen to apply the developed software. The first case study was representative of small-scale application to a community in Córdoba (Spain) where chloroform is predominant and has a low concentration. The second case study was of an intermediate scale in a region in Venezuela, and the third case study was representative of large-scale treatment of water in the Barcelona metropolitan region (Spain). Results showed that case studies with larger scale and higher initial risk offer the best capital investment to decrease the risk. PMID:29562670

Risk Factors Associated with Injury and Mortality from Paediatric Low Speed Vehicle Incidents: A Systematic Review

PubMed Central

Paul Anthikkat, Anne; Page, Andrew; Barker, Ruth

2013-01-01

Objective. This study reviews modifiable risk factors associated with fatal and nonfatal injury from low-speed vehicle runover (LSVRO) incidents involving children aged 0–15 years. Data Sources. Electronic searches for child pedestrian and driveway injuries from the peer-reviewed literature and transport-related websites from 1955 to 2012. Study Selection. 41 studies met the study inclusion criteria. Data Extraction. A systematic narrative summary was conducted that included study design, methodology, risk factors, and other study variables. Results. The most commonly reported risk factors for LSVRO incidents included age under 5 years, male gender, and reversing vehicles. The majority of reported incidents involved residential driveways, but several studies identified other traffic and nontraffic locations. Low socioeconomic status and rental accommodation were also associated with LSVRO injury. Vehicles were most commonly driven by a family member, predominantly a parent. Conclusion. There are a number of modifiable vehicular, environmental, and behavioural factors associated with LSVRO injuries in young children that have been identified in the literature to date. Strategies relating to vehicle design (devices for increased rearward visibility and crash avoidance systems), housing design (physical separation of driveway and play areas), and behaviour (driver behaviour, supervision of young children) are discussed. PMID:23781251

Estimating risk and rate levels, ratios and differences in case-control studies.

PubMed

King, Gary; Zeng, Langche

2002-05-30

Classic (or 'cumulative') case-control sampling designs do not admit inferences about quantities of interest other than risk ratios, and then only by making the rare events assumption. Probabilities, risk differences and other quantities cannot be computed without knowledge of the population incidence fraction. Similarly, density (or 'risk set') case-control sampling designs do not allow inferences about quantities other than the rate ratio. Rates, rate differences, cumulative rates, risks, and other quantities cannot be estimated unless auxiliary information about the underlying cohort such as the number of controls in each full risk set is available. Most scholars who have considered the issue recommend reporting more than just risk and rate ratios, but auxiliary population information needed to do this is not usually available. We address this problem by developing methods that allow valid inferences about all relevant quantities of interest from either type of case-control study when completely ignorant of or only partially knowledgeable about relevant auxiliary population information.

Impact of HealthWise South Africa on Polydrug Use and High-Risk Sexual Behavior

ERIC Educational Resources Information Center

Tibbits, Melissa K.; Smith, Edward A.; Caldwell, Linda L.; Flisher, Alan J.

2011-01-01

This study was designed to evaluate the efficacy of the HealthWise South Africa HIV and substance abuse prevention program at impacting adolescents' polydrug use and sexual risk behaviors. HealthWise is a school-based intervention designed to promote social-emotional skills, increase knowledge and refusal skills relevant to substance use and…

Reproductive History and Breast Cancer Risk

MedlinePlus

... of breast cancer. However, these studies had important design limitations that could have affected the results. A ... bias . Prospective studies , which are more rigorous in design and unaffected by such bias, have consistently shown ...

Tubal risk markers for failure to place transcervical sterilization coils

PubMed Central

Leyser-Whalen, Ophra; Rouhani, Mahta; Rahman, Mahbubur; Berenson, Abbey B

2011-01-01

Background There is a growing body of literature on placement rates of the Essure® procedure, yet prior studies have not attempted to identify tubal-associated risk factors for placement failures. The current study examines risk markers associated with the inability to deploy the Essure® coils into the tubal lumen using the new ESS305 design. Study Design We used electronic medical record data to assess risk markers associated with the inability to place the Essure coils in the tubal lumen using the new ESS305 design. A total of 310 attempted procedures between June 14, 2007, and April 29, 2011 were analyzed. Results There were 18 tubal failures (5.8%) out of the 310 attempted procedures. A history of a prior sexually transmitted infection (STI) was associated with tubal failure (OR 2.64, 95% confidence interval (CI) 1.01–6.90; p=.048). Conclusions We speculate that the observed association between a prior STI and an inability to place the coil was due to a past history of pelvic inflammatory disease. PMID:22036044

Flood risk analysis for flood control and sediment transportation in sandy regions: A case study in the Loess Plateau, China

NASA Astrophysics Data System (ADS)

Guo, Aijun; Chang, Jianxia; Wang, Yimin; Huang, Qiang; Zhou, Shuai

2018-05-01

Traditional flood risk analysis focuses on the probability of flood events exceeding the design flood of downstream hydraulic structures while neglecting the influence of sedimentation in river channels on regional flood control systems. This work advances traditional flood risk analysis by proposing a univariate and copula-based bivariate hydrological risk framework which incorporates both flood control and sediment transport. In developing the framework, the conditional probabilities of different flood events under various extreme precipitation scenarios are estimated by exploiting the copula-based model. Moreover, a Monte Carlo-based algorithm is designed to quantify the sampling uncertainty associated with univariate and bivariate hydrological risk analyses. Two catchments located on the Loess plateau are selected as study regions: the upper catchments of the Xianyang and Huaxian stations (denoted as UCX and UCH, respectively). The univariate and bivariate return periods, risk and reliability in the context of uncertainty for the purposes of flood control and sediment transport are assessed for the study regions. The results indicate that sedimentation triggers higher risks of damaging the safety of local flood control systems compared with the event that AMF exceeds the design flood of downstream hydraulic structures in the UCX and UCH. Moreover, there is considerable sampling uncertainty affecting the univariate and bivariate hydrologic risk evaluation, which greatly challenges measures of future flood mitigation. In addition, results also confirm that the developed framework can estimate conditional probabilities associated with different flood events under various extreme precipitation scenarios aiming for flood control and sediment transport. The proposed hydrological risk framework offers a promising technical reference for flood risk analysis in sandy regions worldwide.

Mapping transmission risk of Lassa fever in West Africa: the importance of quality control, sampling bias, and error weighting.

PubMed

Peterson, A Townsend; Moses, Lina M; Bausch, Daniel G

2014-01-01

Lassa fever is a disease that has been reported from sites across West Africa; it is caused by an arenavirus that is hosted by the rodent M. natalensis. Although it is confined to West Africa, and has been documented in detail in some well-studied areas, the details of the distribution of risk of Lassa virus infection remain poorly known at the level of the broader region. In this paper, we explored the effects of certainty of diagnosis, oversampling in well-studied region, and error balance on results of mapping exercises. Each of the three factors assessed in this study had clear and consistent influences on model results, overestimating risk in southern, humid zones in West Africa, and underestimating risk in drier and more northern areas. The final, adjusted risk map indicates broad risk areas across much of West Africa. Although risk maps are increasingly easy to develop from disease occurrence data and raster data sets summarizing aspects of environments and landscapes, this process is highly sensitive to issues of data quality, sampling design, and design of analysis, with macrogeographic implications of each of these issues and the potential for misrepresenting real patterns of risk.

Meta-analysis of paternal age and schizophrenia risk in male versus female offspring.

PubMed

Miller, Brian; Messias, Erick; Miettunen, Jouko; Alaräisänen, Antti; Järvelin, Marjo-Riita; Koponen, Hannu; Räsänen, Pirkko; Isohanni, Matti; Kirkpatrick, Brian

2011-09-01

Advanced paternal age (APA) is a reported risk factor for schizophrenia in the offspring. We performed a meta-analysis of this association, considering the effect of gender and study design. We identified articles by searching Pub Med, PsychInfo, ISI, and EMBASE, and the reference lists of identified studies. Previously unpublished data from the Northern Finland 1966 Birth Cohort (NFBC 1966) study were also included. There were 6 cohort studies and 6 case-control studies that met the inclusion criteria. In both study designs, there was a significant increase in risk of schizophrenia in the offspring of older fathers (≥30) compared to a reference paternal age of 25-29, with no gender differences. The relative risk (RR) in the oldest fathers (≥50) was 1.66 [95% confidence interval (95% CI): 1.46-1.89, P < 0.01]. A significant increase in risk was also found for younger fathers (<25) in males (RR = 1.08, 95% CI: 1.02-1.14, P = 0.01) but not females (RR = 1.04, 95% CI: 0.97-1.14, P = 0.28). The population attributable risk percentage (PAR%) was 10% for paternal age ≥30 and 5% for paternal age <25. Both APA (≥30) and younger paternal age (<25) increase the risk of schizophrenia; younger paternal age may be associated with an increased risk in males but not females. This risk factor increases the risk of schizophrenia as much as any single candidate gene of risk. The mechanism of these associations is not known and may differ for older and younger fathers.

Classroom-Based Phonological Sensitivity Intervention (PSI) Using a Narrative Platform: An Experimental Study of First Graders at Risk for a Reading Disability

ERIC Educational Resources Information Center

Ritter, Michaela J.; Saxon, Terrill F.

2011-01-01

The purpose of this study was to assess the effectiveness of classroom-based phonological sensitivity intervention (PSI) using a narrative platform for children in first grade who are at risk for a reading disability. Participants consisted of 59 first graders identified as at risk for later reading impairments. At-risk designation was dictated by…

The risk of acute liver injury among users of antibiotic medications: a comparison of case-only studies.

PubMed

Brauer, Ruth; Ruigómez, Ana; Klungel, Olaf; Reynolds, Robert; Feudjo Tepie, Maurille; Smeeth, Liam; Douglas, Ian

2016-03-01

The aims of this study were two-fold: (i) to investigate the effect of exposure to antibiotic agents on the risk of acute liver injury using a self-controlled case series and case-crossover study and (ii) to compare the results between the case-only studies. For the self-controlled case series study relative incidence ratios (IRR) were calculated by dividing the rate of acute liver injury experienced during patients' periods of exposure to antibiotics to patients' rate of events during non-exposed time using conditional Poisson regression. For the case-crossover analysis we calculated Odds Ratios (OR) using conditional logistic regression by comparing exposure during 14- and 30-day risk windows with exposure during control moments. Using the self-controlled case series approach, the IRR was highest during the first 7 days after receipt of a prescription (10.01, 95% CI 6.59-15.18). Omitting post-exposure washout periods lowered the IRR to 7.2. The highest estimate in the case-crossover analysis was found when two 30-day control periods 1 year prior to the 30-day ALI risk period were retained in the analysis: OR = 6.5 (95% CI, 3.95-10.71). The lowest estimate was found when exposure in the 14-day risk period was compared to exposure in four consecutive 14-day control periods immediately prior to the risk period (OR = 3.05, 95% CI, 2.06-4.53). An increased relative risk of acute liver injury was consistently observed using both self-controlled case series and case-crossover designs. Case-only designs can be used as a viable alternative study design to study the risk of acute liver injury, albeit with some limitations. © 2015 The Authors Pharmacoepidemiology and Drug Safety Published by John Wiley & Sons Ltd.

A Cardiovascular Risk Reduction Program for American Indians with Metabolic Syndrome: The Balance Study

ERIC Educational Resources Information Center

Lee, Elisa T.; Jobe, Jared B.; Yeh, Jeunliang; Ali, Tauqeer; Rhoades, Everett R.; Knehans, Allen W.; Willis, Diane J.; Johnson, Melanie R.; Zhang, Ying; Poolaw, Bryce; Rogers, Billy

2012-01-01

The Balance Study is a randomized controlled trial designed to reduce cardiovascular disease (CVD) risk in 200 American Indian (AI) participants with metabolic syndrome who reside in southwestern Oklahoma. Major risk factors targeted include weight, diet, and physical activity. Participants are assigned randomly to one of two groups, a guided or a…

Differentiation, Self-Other Representations, and Rupture-Repair Processes: Predicting Child Maltreatment Risk

ERIC Educational Resources Information Center

Skowron, Elizabeth A.; Kozlowski, JoEllen M.; Pincus, Aaron L.

2010-01-01

This set of studies was designed to examine the relational underpinnings of child abuse potential in a sample of 51 urban families. In Study 1, lower maternal differentiation of self--most notably, greater emotional reactivity and greater emotional cutoff--along with self-attacking introjects distinguished mothers at higher risk (vs. lower risk)…

Relationships of Social Context and Identity to Problem Behavior among High-Risk Hispanic Adolescents

ERIC Educational Resources Information Center

Schwartz, Seth J.; Mason, Craig A.; Pantin, Hilda; Wang, Wei; Brown, C. Hendricks; Campo, Ana E.; Szapocznik, Jose

2009-01-01

The present study was designed to examine (a) family and school functioning and (b) personal and ethnic identity are associated with conduct problems, drug use, and sexual risk taking in a sample of 227 high-risk Hispanic adolescents. Adolescents participated in the study with their primary parents, who were mostly mothers. Adolescents completed…

A Multi-Domain Model of Risk Factors for ODD Symptoms in a Community Sample of 4-Year-Olds

ERIC Educational Resources Information Center

Lavigne, John V.; Gouze, Karen R.; Hopkins, Joyce; Bryant, Fred B.; LeBailly, Susan A.

2012-01-01

Few studies have been designed to assess the pathways by which risk factors are associated with symptoms of psychopathology across multiple domains, including contextual factors, parental depression, parenting, and child characteristics. The present study examines a cross-sectional model of risk factors for symptoms of Oppositional Defiant…

Mathematics Instruction for Middle School Students with and At-Risk for Behavioral Disorders: A Survey Study

ERIC Educational Resources Information Center

Jones, Stacey Eagan Lefort

2012-01-01

This survey study was designed to investigate mathematics instruction for middle school students with and at-risk for emotional and behavioral disorders (EBD). It sought to identify who is teaching mathematics to students with and at-risk for EBD, investigate if mathematics and special education teachers are implementing recommended curricula and…

Joint scientific statement of the European Association for the Study of Obesity and the European Society of Hypertension: Obesity and early vascular ageing.

PubMed

Jordan, Jens; Nilsson, Peter M; Kotsis, Vasilios; Olsen, Michael H; Grassi, Guido; Yumuk, Volkan; Hauner, Hans; Zahorska-Markiewicz, Barbara; Toplak, Hermann; Engeli, Stefan; Finer, Nick

2015-03-01

Current cardiovascular risk scores do not include obesity or fat distribution as independent factors, and may underestimate risk in obese individuals. Assessment of early vascular ageing (EVA) biomarkers including arterial stiffness, central blood pressure, carotid intima-media thickness and flow-mediated vasodilation may help to refine risk assessment in obese individuals in whom traditional cardiovascular risk scores and factors suggest no need for specific medical attention. A number of issues need to be addressed before this approach is ready for translation into routine clinical practice. Methodologies for measurements of vascular markers need to be further standardized and less operator-dependent. The utility of these nontraditional risk factors will also need to be proven in sufficiently large and properly designed interventional studies. Indeed, published studies on vascular markers in obesity and weight loss vary in quality and study design, are sometimes conducted in small populations, use a variety of differing methodologies and study differing vascular beds. Finally, current vascular measurements are still crude and may not be sufficient to cover the different aspects of EVA in obesity.

Evidence mapping of whole grain intervention studies, health outcomes, and reporting practices

USDA-ARS?s Scientific Manuscript database

Higher consumption of whole grain foods is associated with reduced risk of cardiovascular disease, diabetes, and obesity in observational studies; yet, in intervention studies, the effect of whole grains on intermediate markers of risk are mixed. This may be due to the variability in study design, d...

Recommendations for the design of laboratory studies on non-target arthropods for risk assessment of genetically engineered plants

PubMed Central

Hellmich, Richard L.; Candolfi, Marco P.; Carstens, Keri; De Schrijver, Adinda; Gatehouse, Angharad M. R.; Herman, Rod A.; Huesing, Joseph E.; McLean, Morven A.; Raybould, Alan; Shelton, Anthony M.; Waggoner, Annabel

2010-01-01

This paper provides recommendations on experimental design for early-tier laboratory studies used in risk assessments to evaluate potential adverse impacts of arthropod-resistant genetically engineered (GE) plants on non-target arthropods (NTAs). While we rely heavily on the currently used proteins from Bacillus thuringiensis (Bt) in this discussion, the concepts apply to other arthropod-active proteins. A risk may exist if the newly acquired trait of the GE plant has adverse effects on NTAs when they are exposed to the arthropod-active protein. Typically, the risk assessment follows a tiered approach that starts with laboratory studies under worst-case exposure conditions; such studies have a high ability to detect adverse effects on non-target species. Clear guidance on how such data are produced in laboratory studies assists the product developers and risk assessors. The studies should be reproducible and test clearly defined risk hypotheses. These properties contribute to the robustness of, and confidence in, environmental risk assessments for GE plants. Data from NTA studies, collected during the analysis phase of an environmental risk assessment, are critical to the outcome of the assessment and ultimately the decision taken by regulatory authorities on the release of a GE plant. Confidence in the results of early-tier laboratory studies is a precondition for the acceptance of data across regulatory jurisdictions and should encourage agencies to share useful information and thus avoid redundant testing. PMID:20938806

Firefighting to Innovation: Using Human Factors and Ergonomics to Tackle Slip, Trip, and Fall Risks in Hospitals.

PubMed

Hignett, Sue; Wolf, Laurie; Taylor, Ellen; Griffiths, Paula

2015-11-01

The aim of this study was to use a theoretical model (bench) for human factors and ergonomics (HFE) and a comparison with occupational slips, trips, and falls (STFs) risk management to discuss patient STF interventions (bedside). Risk factors for patient STFs have been identified and reported since the 1950s and are mostly unchanged in the 2010s. The prevailing clinical view has been that STF events indicate underlying frailty or illness, and so many of the interventions over the past 60 years have focused on assessing and treating physiological factors (dizziness, illness, vision/hearing, medicines) rather than designing interventions to reduce risk factors at the time of the STF. Three case studies are used to discuss how HFE has been, or could be, applied to STF risk management as (a) a design-based (building) approach to embed safety into the built environment, (b) a staff- (and organization-) based approach, and (c) a patient behavior-based approach to explore and understand patient perspectives of STF events. The results from the case studies suggest taking a similar HFE integration approach to other industries, that is, a sustainable design intervention for the person who experiences the STF event-the patient. This paper offers a proactive problem-solving approach to reduce STFs by patients in acute hospitals. Authors of the three case studies use HFE principles (bench/book) to understand the complex systems for facility and equipment design and include the perspective of all stakeholders (bedside). © 2015, Human Factors and Ergonomics Society.

Understanding the Links Between Self-Report Emotional Intelligence and Suicide Risk: Does Psychological Distress Mediate This Relationship Across Time and Samples?

PubMed Central

Mérida-López, Sergio; Extremera, Natalio; Rey, Lourdes

2018-01-01

Objective: In the last decades, increasing attention has been paid to examining psychological resources that might contribute to our understanding of suicide risk. Although Emotional Intelligence (EI) is one dimension that has been linked with decreased suicidal ideation and behaviors, we detected several gaps in the literature in this area regarding the research designs and samples involved. In this research, we aimed to test a mediator model considering self-report EI, psychological distress and suicide risk across samples adopting both cross-sectional and prospective designs in two independent studies. Method: In Study 1, our purpose was to examine the potential role of psychological distress as a mediator in the relationship between self-report EI and suicide risk in a community sample comprised of 438 adults (270 women; mean age: 33.21 years). In Study 2, we sought to examine the proposed mediator model considering a 2-month prospective design in a sample of college students (n = 330 in T1; n = 311 in T2; 264 women; mean age: 22.22 years). Results: In Study 1, we found that psychological distress partially mediated the effect of self-report EI on suicide risk. More interestingly, findings from Study 2 showed that psychological distress fully mediated the relationship between self-report EI and suicide risk at Time 2. Conclusion: These results point out the role of psychological distress as a mediator in the association between self-report EI and suicide risk. These findings suggest an underlying process by which self-report EI may act as a protective factor against suicidal ideation and behaviors. In line with the limitations of our work, plausible avenues for future research and interventions are discussed. PMID:29867607

Physical activity barriers and motivators among high-risk employees.

PubMed

Paguntalan, John C; Gregoski, Mathew

2016-11-22

Worksite wellness programs offer an ideal setting to target high-risk sedentary workers to improve health status. Lack of physical activity is associated with increased risk for coronary heart disease and mortality. Despite the risks, the number of sedentary workers is increasing. This study examined the perceived barriers and motivators for physical activity among employees at high-risk for coronary heart disease. A purposive sample of 24 high-risk workers participating in a wellness program in rural South Carolina were enrolled in the study. Qualitative data was obtained through semi-structured face-to-face interviews. Grounded theory was used to analyze qualitative data, and identify overarching themes. Physical limitations due to pain and weakness, lack of motivation, and lack of time emerged as the main barriers to physical activity. Family relationships were reported as the strongest motivator along with social support and potential health benefits. Findings highlight the unique experience of high-risk workers with physical activity. The findingsunderscore the need to design and implement effective interventions specifically designed to meet the needs of high-risk employees.

Quantification of increased flood risk due to global climate change for urban river management planning.

PubMed

Morita, M

2011-01-01

Global climate change is expected to affect future rainfall patterns. These changes should be taken into account when assessing future flooding risks. This study presents a method for quantifying the increase in flood risk caused by global climate change for use in urban flood risk management. Flood risk in this context is defined as the product of flood damage potential and the probability of its occurrence. The study uses a geographic information system-based flood damage prediction model to calculate the flood damage caused by design storms with different return periods. Estimation of the monetary damages these storms produce and their return periods are precursors to flood risk calculations. The design storms are developed from modified intensity-duration-frequency relationships generated by simulations of global climate change scenarios (e.g. CGCM2A2). The risk assessment method is applied to the Kanda River basin in Tokyo, Japan. The assessment provides insights not only into the flood risk cost increase due to global warming, and the impact that increase may have on flood control infrastructure planning.

Reply to Commentary: "Are HIV-Infected Candidates for Participation in Risky Cure-Related Studies Otherwise Healthy?"

PubMed

Dubé, Karine; Sylla, Laurie; Dee, Lynda

2018-02-01

We respond to Eyal et al.'s commentary focusing on how people living with HIV participating in HIV cure-related studies are defined. We argue that the types of participants enrolled in research cannot be dissociated from the study interventions, the types of anticipated risks, and the background standard of care. As the field of HIV cure research advances, more nuance and granularity will be needed to define research criteria and acceptable risk/benefit ratios for cure study participants, as well as specific tiered protocol designs that serve to protect various participant populations from untoward risks, especially in very early phase research with interventions known to have potentially serious toxicities. We highlight key lessons from the ACTIVATE study involving a latency-reversing agent, Panobinostat, for HIV cure study design involving "otherwise healthy volunteers".

Delineating risk zones and evaluation of shelter centres for flood disaster management along the Pahang River Basin, Malaysia

PubMed Central

Isahak, Anizan; Siwar, Chamhuri; Ismail, Shaharuddin M.; Hanafi, Zulkifli; Zainuddin, Mohd S.

2018-01-01

Shelter centres are important locations to safeguard people from helpless situations and are an integral part of disaster risk reduction (DRR), particularly for flood DRR. The establishment of shelter centres, and their design based on scientific assessment, is crucial. Yet, they are very much related to the geographic location, socio-economic conditions and the livelihoods of the affected communities. However, many parts of the developing world are still lagging behind in ensuring such scientific design. Considering the flood disaster in 2014 that affected the residents living along the Pahang River Basin, in this study we delineate the communities at risk and evaluate the existing shelter centres to determine how they reduce people’s vulnerability to the risks associated with rural and urban landscapes. We used spatial analysis tools to delineate risk zones and to evaluate existing evacuation systems. A flood disaster risk map was produced to determine which communities are living with risks. Subsequently, the distribution of shelter centres examined whether they are able to support people living at the flood risk zones. These centres were also evaluated using a set of international guidelines for effective disaster shelters. This reveals that the number of shelter centres is not adequate. The designation and designing of shelter centres are not being done scientifically. The maps produced here have a lot of potential to support disaster management decisions, in particular site selection and the prioritisation of centres. The study concludes with a set of guidelines and recommendations for structural and non-structural measures, such as alternative livelihoods and the potential of ecotourism, which may improve the resilience among flood-affected communities; and the decision-making process for the overall flood DRR initiatives.

Guidelines for contingency planning NASA (National Aeronautics and Space Administration) ADP security risk reduction decision studies

NASA Technical Reports Server (NTRS)

Tompkins, F. G.

1984-01-01

Guidance is presented to NASA Computer Security Officials for determining the acceptability or unacceptability of ADP security risks based on the technical, operational and economic feasibility of potential safeguards. The risk management process is reviewed as a specialized application of the systems approach to problem solving and information systems analysis and design. Reporting the results of the risk reduction analysis to management is considered. Report formats for the risk reduction study are provided.

Evaluation of a Web-Based Malaria Risk Reduction Game for Study Abroad Students

PubMed Central

Hartjes, Laurie B.; Baumann, Linda C.

2012-01-01

Objective Compare feedback strategies in three versions of an educational game. Participants Study abroad students (N = 482) participated by playing the game and completing pre-game/post-game surveys January-March 2010. Methods This study employed an experimental design. Primary outcome measures were knowledge gain, player-satisfaction, and risk perception. Results One-third had previously traveled to a malaria-risk region and two-thirds planned to do so. Baseline malaria knowledge was low. Post-game knowledge and risk perception were significantly higher than pre-game, irrespective of past travel status. The group that automatically received explanatory feedback following game decisions scored higher for mean knowledge gain, without differences in player-satisfaction. Conclusions The challenges of designing a feedback strategy to support Web-based learning make these results highly relevant to health educators developing interactive multimedia interventions. The increasing number of students traveling to higher-risk destinations demands attention. Both malaria-naive and malaria-experienced students would benefit from this approach to travel health education. PMID:22686363

Evaluation of a Web-based malaria risk reduction game for study abroad students.

PubMed

Hartjes, Laurie B; Baumann, Linda C

2012-01-01

Compare feedback strategies in 3 versions of an educational game. Study abroad students (N = 482) participated by playing the game and completing pregame/postgame surveys January-March 2010. This study employed an experimental design. Primary outcome measures were knowledge gain, player satisfaction, and risk perception. One-third had previously traveled to a malaria-risk region, and two thirds planned to do so. Baseline malaria knowledge was low. Postgame knowledge and risk perception were significantly higher than pregame, irrespective of past travel status. The group that automatically received explanatory feedback following game decisions scored higher for mean knowledge gain, without differences in player satisfaction. The challenges of designing a feedback strategy to support Web-based learning make these results highly relevant to health educators developing interactive multimedia interventions. The increasing number of students traveling to higher-risk destinations demands attention. Both malaria-naive and malaria-experienced students would benefit from this approach to travel health education.

Using a Systematic Conceptual Model for a Process Evaluation of a Middle School Obesity Risk-Reduction Nutrition Curriculum Intervention: "Choice, Control & Change"

ERIC Educational Resources Information Center

Lee, Heewon; Contento, Isobel R.; Koch, Pamela

2013-01-01

Objective: To use and review a conceptual model of process evaluation and to examine the implementation of a nutrition education curriculum, "Choice, Control & Change", designed to promote dietary and physical activity behaviors that reduce obesity risk. Design: A process evaluation study based on a systematic conceptual model. Setting: Five…

Diesel Exhaust in Miners Study: Q&A

Cancer.gov

The Diesel Exhaust in Miners Study was designed to evaluate the risk of death associated with diesel exhaust exposure, particularly as it may relate to lung cancer. The researchers observed increased risk for lung cancer death with increasing levels of ex

Tornado risks and design windspeeds for the Oak Ridge Plant Site

DOE Office of Scientific and Technical Information (OSTI.GOV)

Not Available

1975-08-01

The effects of tornadoes and other extreme winds should be considered in establishing design criteria for structures to resist wind loads. Design standards that are incorporated in building codes do not normally include the effects of tornadoes in their wind load criteria. Some tornado risk models ignore the presence of nontornadic extreme winds. The purpose of this study is to determine the probability of tornadic and straight winds exceeding a threshold value in the geographical region surrounding the Oak Ridge, Tennessee plant site.

Scientific Message Translation and the Heuristic Systematic Model: Insights for Designing Educational Messages About Progesterone and Breast Cancer Risks

PubMed Central

Perrault, Evan; Smith, Sandi; Keating, David M.; Nazione, Samantha; Silk, Kami; Russell, Jessica

2017-01-01

Results of ongoing scientific research on environmental determinants of breast cancer are not typically presented to the public in ways they can easily understand and use to take preventive actions. In this study, results of scientific studies on progesterone exposure as a risk factor for breast cancer were translated into high and low literacy level messages. Using the heuristic systematic model, this study examined how ability, motivation, and message processing (heuristic and systematic) influenced perceptions of risk beliefs and negative attitudes about progesterone exposure among women who read the translated scientific messages. Among the 1254 participants, those given the higher literacy level message had greater perceptions of risk about progesterone. Heuristic message cues of source credibility and perceived message quality, as well as motivation, also predicted risk beliefs. Finally, risk beliefs were a strong predictor of negative attitudes about exposure to progesterone. The results can help improve health education message design in terms of practitioners having better knowledge of message features that are the most persuasive to the target audiences on this topic. PMID:25903053

Predicting Risk of Type 2 Diabetes Mellitus with Genetic Risk Models on the Basis of Established Genome-wide Association Markers: A Systematic Review

PubMed Central

Bao, Wei; Hu, Frank B.; Rong, Shuang; Rong, Ying; Bowers, Katherine; Schisterman, Enrique F.; Liu, Liegang; Zhang, Cuilin

2013-01-01

This study aimed to evaluate the predictive performance of genetic risk models based on risk loci identified and/or confirmed in genome-wide association studies for type 2 diabetes mellitus. A systematic literature search was conducted in the PubMed/MEDLINE and EMBASE databases through April 13, 2012, and published data relevant to the prediction of type 2 diabetes based on genome-wide association marker–based risk models (GRMs) were included. Of the 1,234 potentially relevant articles, 21 articles representing 23 studies were eligible for inclusion. The median area under the receiver operating characteristic curve (AUC) among eligible studies was 0.60 (range, 0.55–0.68), which did not differ appreciably by study design, sample size, participants’ race/ethnicity, or the number of genetic markers included in the GRMs. In addition, the AUCs for type 2 diabetes did not improve appreciably with the addition of genetic markers into conventional risk factor–based models (median AUC, 0.79 (range, 0.63–0.91) vs. median AUC, 0.78 (range, 0.63–0.90), respectively). A limited number of included studies used reclassification measures and yielded inconsistent results. In conclusion, GRMs showed a low predictive performance for risk of type 2 diabetes, irrespective of study design, participants’ race/ethnicity, and the number of genetic markers included. Moreover, the addition of genome-wide association markers into conventional risk models produced little improvement in predictive performance. PMID:24008910

My Family Medical History and Me: A pilot feasibility study of a cardiovascular risk reduction intervention

PubMed Central

Imes, Christopher C.; Lewis, Frances M.; Austin, Melissa A.; Dougherty, Cynthia M.

2014-01-01

Objective Evaluate the feasibility and acceptability of a behaviorally-focused intervention designed to increase perceived cardiovascular disease (CVD) and coronary heart disease (CHD) risk in young adults with a family history (FH) of CVD/CHD. Design Single group, pre-post-test design. Sample Fifteen, mostly female (n=13, 86.7%), White, young adults (mean age 20.8 years) with a minimum of a high school education with a FH of CVD/CHD. Measurements Feasibility examined the recruitment strategy, study procedures, appropriateness and quality of the study instruments, and problems that occurred during delivery of the intervention. Acceptability examined participants' engagement in the in person sessions and at home exercises and their feedback about the intervention. Intervention Two, in person sessions provided personalized, tailored messages about ten-year and lifetime CHD risk based on risk factors, FH from a three-generation pedigree, lipid levels, blood pressure, and smoking status, and brief counseling about how to engage in a healthy lifestyle to decrease CVD/CHD risk. Results The intervention was feasible and acceptable. Participants requested more information on healthy food choices, including which foods to avoid and which exercises most improve cardiovascular health. Conclusions Although requiring refinement, the intervention has potential public health implications and deserves further testing. PMID:24840334

Reliability and Probabilistic Risk Assessment - How They Play Together

NASA Technical Reports Server (NTRS)

Safie, Fayssal; Stutts, Richard; Huang, Zhaofeng

2015-01-01

Since the Space Shuttle Challenger accident in 1986, NASA has extensively used probabilistic analysis methods to assess, understand, and communicate the risk of space launch vehicles. Probabilistic Risk Assessment (PRA), used in the nuclear industry, is one of the probabilistic analysis methods NASA utilizes to assess Loss of Mission (LOM) and Loss of Crew (LOC) risk for launch vehicles. PRA is a system scenario based risk assessment that uses a combination of fault trees, event trees, event sequence diagrams, and probability distributions to analyze the risk of a system, a process, or an activity. It is a process designed to answer three basic questions: 1) what can go wrong that would lead to loss or degraded performance (i.e., scenarios involving undesired consequences of interest), 2) how likely is it (probabilities), and 3) what is the severity of the degradation (consequences). Since the Challenger accident, PRA has been used in supporting decisions regarding safety upgrades for launch vehicles. Another area that was given a lot of emphasis at NASA after the Challenger accident is reliability engineering. Reliability engineering has been a critical design function at NASA since the early Apollo days. However, after the Challenger accident, quantitative reliability analysis and reliability predictions were given more scrutiny because of their importance in understanding failure mechanism and quantifying the probability of failure, which are key elements in resolving technical issues, performing design trades, and implementing design improvements. Although PRA and reliability are both probabilistic in nature and, in some cases, use the same tools, they are two different activities. Specifically, reliability engineering is a broad design discipline that deals with loss of function and helps understand failure mechanism and improve component and system design. PRA is a system scenario based risk assessment process intended to assess the risk scenarios that could lead to a major/top undesirable system event, and to identify those scenarios that are high-risk drivers. PRA output is critical to support risk informed decisions concerning system design. This paper describes the PRA process and the reliability engineering discipline in detail. It discusses their differences and similarities and how they work together as complementary analyses to support the design and risk assessment processes. Lessons learned, applications, and case studies in both areas are also discussed in the paper to demonstrate and explain these differences and similarities.

Study designs for identification of rare disease variants in complex diseases: the utility of family-based designs.

PubMed

Ionita-Laza, Iuliana; Ottman, Ruth

2011-11-01

The recent progress in sequencing technologies makes possible large-scale medical sequencing efforts to assess the importance of rare variants in complex diseases. The results of such efforts depend heavily on the use of efficient study designs and analytical methods. We introduce here a unified framework for association testing of rare variants in family-based designs or designs based on unselected affected individuals. This framework allows us to quantify the enrichment in rare disease variants in families containing multiple affected individuals and to investigate the optimal design of studies aiming to identify rare disease variants in complex traits. We show that for many complex diseases with small values for the overall sibling recurrence risk ratio, such as Alzheimer's disease and most cancers, sequencing affected individuals with a positive family history of the disease can be extremely advantageous for identifying rare disease variants. In contrast, for complex diseases with large values of the sibling recurrence risk ratio, sequencing unselected affected individuals may be preferable.

Prevention of fall incidents in patients with a high risk of falling: design of a randomised controlled trial with an economic evaluation of the effect of multidisciplinary transmural care

PubMed Central

Peeters, Geeske MEE; de Vries, Oscar J; Elders, Petra JM; Pluijm, Saskia MF; Bouter, Lex M; Lips, Paul

2007-01-01

Background Annually, about 30% of the persons of 65 years and older falls at least once and 15% falls at least twice. Falls often result in serious injuries, such as fractures. Therefore, the prevention of accidental falls is necessary. The aim is to describe the design of a study that evaluates the efficacy and cost-effectiveness of a multidisciplinary assessment and treatment of multiple fall risk factors in independently living older persons with a high risk of falling. Methods/Design The study is designed as a randomised controlled trial (RCT) with an economic evaluation. Independently living persons of 65 years and older who recently experienced a fall are interviewed in their homes and screened for risk of recurrent falling using a validated fall risk profile. Persons at low risk of recurrent falling are excluded from the RCT. Persons who have a high risk of recurrent falling are blindly randomised into an intervention (n = 100) or usual care (n = 100) group. The intervention consists of a multidisciplinary assessment and treatment of multifactorial fall risk factors. The transmural multidisciplinary appraoch entails close cooperation between geriatrician, primary care physician, physical therapist and occupational therapist and can be extended with other specialists if relevant. A fall calendar is used to record falls during one year of follow-up. Primary outcomes are time to first and second falls. Three, six and twelve months after the home visit, questionnaires for economic evaluation are completed. After one year, during a second home visit, the secondary outcome measures are reassessed and the adherence to the interventions is evaluated. Data will be analysed according to the intention-to-treat principle and also an on-treatment analysis will be performed. Discussion Strengths of this study are the selection of persons at high risk of recurrent falling followed by a multidisciplinary intervention, its transmural character and the evaluation of adherence. If proven effective, implementation of our multidisciplinary assessment followed by treatment of fall risk factors will reduce the incidence of falls. Trial registration Current Controlled Trials ISRCTN11546541. PMID:17605771

Assessing reservoir operations risk under climate change

USGS Publications Warehouse

Brekke, L.D.; Maurer, E.P.; Anderson, J.D.; Dettinger, M.D.; Townsley, E.S.; Harrison, A.; Pruitt, T.

2009-01-01

Risk-based planning offers a robust way to identify strategies that permit adaptive water resources management under climate change. This paper presents a flexible methodology for conducting climate change risk assessments involving reservoir operations. Decision makers can apply this methodology to their systems by selecting future periods and risk metrics relevant to their planning questions and by collectively evaluating system impacts relative to an ensemble of climate projection scenarios (weighted or not). This paper shows multiple applications of this methodology in a case study involving California's Central Valley Project and State Water Project systems. Multiple applications were conducted to show how choices made in conducting the risk assessment, choices known as analytical design decisions, can affect assessed risk. Specifically, risk was reanalyzed for every choice combination of two design decisions: (1) whether to assume climate change will influence flood-control constraints on water supply operations (and how), and (2) whether to weight climate change scenarios (and how). Results show that assessed risk would motivate different planning pathways depending on decision-maker attitudes toward risk (e.g., risk neutral versus risk averse). Results also show that assessed risk at a given risk attitude is sensitive to the analytical design choices listed above, with the choice of whether to adjust flood-control rules under climate change having considerably more influence than the choice on whether to weight climate scenarios. Copyright 2009 by the American Geophysical Union.

External model validation of binary clinical risk prediction models in cardiovascular and thoracic surgery.

PubMed

Hickey, Graeme L; Blackstone, Eugene H

2016-08-01

Clinical risk-prediction models serve an important role in healthcare. They are used for clinical decision-making and measuring the performance of healthcare providers. To establish confidence in a model, external model validation is imperative. When designing such an external model validation study, thought must be given to patient selection, risk factor and outcome definitions, missing data, and the transparent reporting of the analysis. In addition, there are a number of statistical methods available for external model validation. Execution of a rigorous external validation study rests in proper study design, application of suitable statistical methods, and transparent reporting. Copyright © 2016 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.

Applying machine learning to pattern analysis for automated in-design layout optimization

NASA Astrophysics Data System (ADS)

Cain, Jason P.; Fakhry, Moutaz; Pathak, Piyush; Sweis, Jason; Gennari, Frank; Lai, Ya-Chieh

2018-04-01

Building on previous work for cataloging unique topological patterns in an integrated circuit physical design, a new process is defined in which a risk scoring methodology is used to rank patterns based on manufacturing risk. Patterns with high risk are then mapped to functionally equivalent patterns with lower risk. The higher risk patterns are then replaced in the design with their lower risk equivalents. The pattern selection and replacement is fully automated and suitable for use for full-chip designs. Results from 14nm product designs show that the approach can identify and replace risk patterns with quantifiable positive impact on the risk score distribution after replacement.

Manual handling of highway kerbs--focus group findings.

PubMed

Bust, P D; Gibb, A G F; Haslam, R A

2005-07-01

The manual handling of concrete highway kerbs remains commonplace in the construction industry despite obvious risks to operatives. This study was undertaken to find out why kerb installation still includes manual handling, to identify the alternatives that exist and to consider how the organisation of the work affects exposure to risk. Focus groups were held with industry professionals to discuss kerb design, installation and the training of operatives, with site visits and interviews undertaken to place the focus group findings in context. The focus group discussions highlighted manufacturer's "myopia", a lack of installation knowledge of designers and shortfalls in training for installation work. It was concluded that risks to the health of construction workers remain as they are not considered in the design of the product, design of the work or ameliorated by adequate risk assessment. Recommendations from the research are that a pro-active approach to health needs to be adopted by the manufacturers of heavy construction products. Designers of work requiring the use of heavy products need to have more experience of site operations, and education and training in manual handling is desirable at all levels in construction organisations.

Comparative Study of Barotrauma Risk during Fish Passage through Kaplan Turbines

DOE Office of Scientific and Technical Information (OSTI.GOV)

Richmond, Marshall C.; Romero-Gomez, Pedro; Serkowski, John A.

Rapid pressure changes in hydroelectric turbine flows can cause barotrauma that can be hazardous to the passage of fish, in particular migratory juvenile salmonids. Although numerous laboratory tests have evaluated the effect of rapid decompression in fish species of relevance, numerical modeling studies offer the advantage of predicting, for new turbine designs, the potential risks of mortality and injury from rapid pressure change during turbine passage. However, rapid pressure change is only one of several hydraulic risks encountered by fish during turbine passage in addition to blade strike, shear, and turbulence. To better understand the role of rapid pressure changes,more » the present work focuses on the application of a computational fluid dynamics based method for evaluating the risk of pressure-related mortality to fish passing through an early 1960s era original hydroelectric Kaplan turbine at Wanapum Dam (Columbia River, Washington), and a modern advanced Kaplan turbine installed in 2005. The results show that the modeling approach acceptably reproduced the nadir pressure distributions compared to field data previously collected at the site using an autonomous sensor. Our findings show that the new advanced-design unit performs better, in terms of reduced barotrauma risk to fish from exposure to low pressures, than the original turbine unit. The outcomes allow for comparative analyses of turbine designs and operations prior to installation, an advantage that can potentially be integrated in the process of designing new turbine units to achieve superior environmental performance. Overall, the results show that modern turbine designs can achieve the multiple objectives of increasing power generation, lowering cavitation potential, and reducing barotrauma risks to passing fish.« less

Flavonoids, Flavonoid Subclasses, and Esophageal Cancer Risk: A Meta-Analysis of Epidemiologic Studies.

PubMed

Cui, Lingling; Liu, Xinxin; Tian, Yalan; Xie, Chen; Li, Qianwen; Cui, Han; Sun, Changqing

2016-06-08

Flavonoids have been suggested to play a chemopreventive role in carcinogenesis. However, the epidemiologic studies assessing dietary intake of flavonoids and esophageal cancer risk have yielded inconsistent results. This study was designed to examine the association between flavonoids, each flavonoid subclass, and the risk of esophageal cancer with a meta-analysis approach. We searched for all relevant studies with a prospective cohort or case-control study design published from January 1990 to April 2016, using PUBMED, EMBASE, and Web of Science. Pooled odds ratios (ORs) were calculated using fixed or random-effect models. In total, seven articles including 2629 cases and 481,193 non-cases were selected for the meta-analysis. Comparing the highest-intake patients with the lowest-intake patients for total flavonoids and for each flavonoid subclass, we found that anthocyanidins (OR = 0.60, 95% CI: 0.49-0.74), flavanones (OR = 0.65, 95% CI: 0.49-0.86), and flavones (OR = 0.78, 95% CI 0.64-0.95) were inversely associated with the risk of esophageal cancer. However, total flavonoids showed marginal association with esophageal cancer risk (OR = 0.78, 95% CI: 0.59-1.04). In conclusion, our study suggested that dietary intake of total flavonoids, anthocyanidins, flavanones, and flavones might reduce the risk of esophageal cancer.

Space Shuttle Probabilistic Risk Assessment (SPRA) Iteration 3.2

NASA Technical Reports Server (NTRS)

Boyer, Roger L.

2010-01-01

The Shuttle is a very reliable vehicle in comparison with other launch systems. Much of the risk posed by Shuttle operations is related to fundamental aspects of the spacecraft design and the environments in which it operates. It is unlikely that significant design improvements can be implemented to address these risks prior to the end of the Shuttle program. The model will continue to be used to identify possible emerging risk drivers and allow management to make risk-informed decisions on future missions. Potential uses of the SPRA in the future include: - Calculate risk impact of various mission contingencies (e.g. late inspection, crew rescue, etc.). - Assessing the risk impact of various trade studies (e.g. flow control valves). - Support risk analysis on mission specific events, such as in flight anomalies. - Serve as a guiding star and data source for future NASA programs.

Multiple Identification and Risks: Examination of Peer Factors across Multiracial and Single-Race Youth

ERIC Educational Resources Information Center

Choi, Yoonsun; He, Michael; Herrenkohl, Todd I.; Catalano, Richard F.; Toumbourou, John W.

2012-01-01

Multiracial youth are thought to be more vulnerable to peer-related risk factors than are single-race youth. However, there have been surprisingly few well-designed studies on this topic. This study empirically investigated the extent to which multiracial youth are at higher risk for peer influenced problem behavior. Data are from a representative…

Risk Factors of Falls in Community-Dwelling Older Adults: Logistic Regression Tree Analysis

ERIC Educational Resources Information Center

Yamashita, Takashi; Noe, Douglas A.; Bailer, A. John

2012-01-01

Purpose of the Study: A novel logistic regression tree-based method was applied to identify fall risk factors and possible interaction effects of those risk factors. Design and Methods: A nationally representative sample of American older adults aged 65 years and older (N = 9,592) in the Health and Retirement Study 2004 and 2006 modules was used.…

An evaluation of venous thromboembolic risk in acutely ill medical patients immobilized at home: the AT-HOME Study.

PubMed

Haas, Sylvia K; Hach-Wunderle, Viola; Mader, Frank H; Ruster, Katherine; Paar, Wilhelm D

2007-01-01

Many risk factors for venous thromboembolism (VTE) in hospitalized medical patients are also present in medical outpatients. VTE prevention represents an important challenge for physicians treating patients at home. The AT-HOME study was a prospective cross-sectional observational study designed to assess awareness of the risk of VTE in immobilized acutely ill medical outpatients among German physicians, many of whom were participating in a national Continuing Medical Education (CME) program designed to raise awareness of VTE. The study involved 1210 medical patients who were acutely confined to bed at home. Physicians performed a subjective assessment of VTE risk, which was rated on a 10-point scale (1 = very low risk; 10 = very high risk). The risk of VTE was also assessed retrospectively by using a scorecard developed for use in hospitalized medical patients. Of the 1210 patients, 198 (16%) had risk scores of 0-4, 319 (26%) had scores of 5 or 6, and 693 (57%) had scores > or =7. Overall, 966 patients (80%) received thromboprophylaxis. The proportion of patients receiving thromboprophylaxis was 0% to 47% in risk score groups 0-4, 76% to 85% in groups 5 and 6, and 90% to 100% in risk score groups 7-10. In the retrospective assessment of VTE risk, 74% of patients were at high risk, 15% were at intermediate risk, and 11% were at low risk. The proportions of patients receiving thromboprophylaxis in these groups were 87%, 61%, and 55%, respectively. The involvement of physicians in educational activities focusing on VTE awareness appeared to create awareness of the risks of VTE in acutely ill medical outpatients.

INTEGRATING EPIDEMIOLOGY AND TOXICOLOGY IN NEUROTOXICITY RISK ASSESSMENT.

EPA Science Inventory

This manuscript provides an overview of the use of data from toxicology and epidemiology studies for neurotoxicity risk assessment. Parameters such as the use of subjects, study designs, exposures, and measured outcomes are compared and contrasted. The main concern for use of d...

Game Theory and Risk-Based Levee System Design

NASA Astrophysics Data System (ADS)

Hui, R.; Lund, J. R.; Madani, K.

2014-12-01

Risk-based analysis has been developed for optimal levee design for economic efficiency. Along many rivers, two levees on opposite riverbanks act as a simple levee system. Being rational and self-interested, land owners on each river bank would tend to independently optimize their levees with risk-based analysis, resulting in a Pareto-inefficient levee system design from the social planner's perspective. Game theory is applied in this study to analyze decision making process in a simple levee system in which the land owners on each river bank develop their design strategies using risk-based economic optimization. For each land owner, the annual expected total cost includes expected annual damage cost and annualized construction cost. The non-cooperative Nash equilibrium is identified and compared to the social planner's optimal distribution of flood risk and damage cost throughout the system which results in the minimum total flood cost for the system. The social planner's optimal solution is not feasible without appropriate level of compensation for the transferred flood risk to guarantee and improve conditions for all parties. Therefore, cooperative game theory is then employed to develop an economically optimal design that can be implemented in practice. By examining the game in the reversible and irreversible decision making modes, the cost of decision making myopia is calculated to underline the significance of considering the externalities and evolution path of dynamic water resource problems for optimal decision making.

Ratio measures in leading medical journals: structured review of accessibility of underlying absolute risks

PubMed Central

Schwartz, Lisa M; Dvorin, Evan L; Welch, H Gilbert

2006-01-01

Objective To examine the accessibility of absolute risk in articles reporting ratio measures in leading medical journals. Design Structured review of abstracts presenting ratio measures. Setting Articles published between 1 June 2003 and 1 May 2004 in Annals of Internal Medicine, BMJ, Journal of the American Medical Association, Journal of the National Cancer Institute, Lancet, and New England Journal of Medicine. Participants 222 articles based on study designs in which absolute risks were directly calculable (61 randomised trials, 161 cohort studies). Main outcome measure Accessibility of the absolute risks underlying the first ratio measure in the abstract. Results 68% of articles (150/222) failed to report the underlying absolute risks for the first ratio measure in the abstract (range 55−81% across the journals). Among these articles, about half did report the underlying absolute risks elsewhere in the article (text, table, or figure) but half did not report them anywhere. Absolute risks were more likely to be reported in the abstract for randomised trials compared with cohort studies (62% v 21%; relative risk 3.0, 95% confidence interval 2.1 to 4.2) and for studies reporting crude compared with adjusted ratio measures (62% v 21%; relative risk 3.0, 2.1 to 4.3). Conclusion Absolute risks are often not easily accessible in articles reporting ratio measures and sometimes are missing altogether—this lack of accessibility can easily exaggerate readers' perceptions of benefit or harm. PMID:17060338

Does Metformin Reduce Cancer Risks? Methodologic Considerations.

PubMed

Golozar, Asieh; Liu, Shuiqing; Lin, Joeseph A; Peairs, Kimberly; Yeh, Hsin-Chieh

2016-01-01

The substantial burden of cancer and diabetes and the association between the two conditions has been a motivation for researchers to look for targeted strategies that can simultaneously affect both diseases and reduce their overlapping burden. In the absence of randomized clinical trials, researchers have taken advantage of the availability and richness of administrative databases and electronic medical records to investigate the effects of drugs on cancer risk among diabetic individuals. The majority of these studies suggest that metformin could potentially reduce cancer risk. However, the validity of this purported reduction in cancer risk is limited by several methodological flaws either in the study design or in the analysis. Whether metformin use decreases cancer risk relies heavily on the availability of valid data sources with complete information on confounders, accurate assessment of drug use, appropriate study design, and robust analytical techniques. The majority of the observational studies assessing the association between metformin and cancer risk suffer from methodological shortcomings and efforts to address these issues have been incomplete. Future investigations on the association between metformin and cancer risk should clearly address the methodological issues due to confounding by indication, prevalent user bias, and time-related biases. Although the proposed strategies do not guarantee a bias-free estimate for the association between metformin and cancer, they will reduce synthesis of and reporting of erroneous results.

An Integrated Approach to Risk Assessment for Concurrent Design

NASA Technical Reports Server (NTRS)

Meshkat, Leila; Voss, Luke; Feather, Martin; Cornford, Steve

2005-01-01

This paper describes an approach to risk assessment and analysis suited to the early phase, concurrent design of a space mission. The approach integrates an agile, multi-user risk collection tool, a more in-depth risk analysis tool, and repositories of risk information. A JPL developed tool, named RAP, is used for collecting expert opinions about risk from designers involved in the concurrent design of a space mission. Another in-house developed risk assessment tool, named DDP, is used for the analysis.

Cancer risks near nuclear facilities: the importance of research design and explicit study hypotheses.

PubMed

Wing, Steve; Richardson, David B; Hoffmann, Wolfgang

2011-04-01

In April 2010, the U.S. Nuclear Regulatory Commission asked the National Academy of Sciences to update a 1990 study of cancer risks near nuclear facilities. Prior research on this topic has suffered from problems in hypothesis formulation and research design. We review epidemiologic principles used in studies of generic exposure-response associations and in studies of specific sources of exposure. We then describe logical problems with assumptions, formation of testable hypotheses, and interpretation of evidence in previous research on cancer risks near nuclear facilities. Advancement of knowledge about cancer risks near nuclear facilities depends on testing specific hypotheses grounded in physical and biological mechanisms of exposure and susceptibility while considering sample size and ability to adequately quantify exposure, ascertain cancer cases, and evaluate plausible confounders. Next steps in advancing knowledge about cancer risks near nuclear facilities require studies of childhood cancer incidence, focus on in utero and early childhood exposures, use of specific geographic information, and consideration of pathways for transport and uptake of radionuclides. Studies of cancer mortality among adults, cancers with long latencies, large geographic zones, and populations that reside at large distances from nuclear facilities are better suited for public relations than for scientific purposes.

Developing safety performance functions incorporating reliability-based risk measures.

PubMed

Ibrahim, Shewkar El-Bassiouni; Sayed, Tarek

2011-11-01

Current geometric design guides provide deterministic standards where the safety margin of the design output is generally unknown and there is little knowledge of the safety implications of deviating from these standards. Several studies have advocated probabilistic geometric design where reliability analysis can be used to account for the uncertainty in the design parameters and to provide a risk measure of the implication of deviation from design standards. However, there is currently no link between measures of design reliability and the quantification of safety using collision frequency. The analysis presented in this paper attempts to bridge this gap by incorporating a reliability-based quantitative risk measure such as the probability of non-compliance (P(nc)) in safety performance functions (SPFs). Establishing this link will allow admitting reliability-based design into traditional benefit-cost analysis and should lead to a wider application of the reliability technique in road design. The present application is concerned with the design of horizontal curves, where the limit state function is defined in terms of the available (supply) and stopping (demand) sight distances. A comprehensive collision and geometric design database of two-lane rural highways is used to investigate the effect of the probability of non-compliance on safety. The reliability analysis was carried out using the First Order Reliability Method (FORM). Two Negative Binomial (NB) SPFs were developed to compare models with and without the reliability-based risk measures. It was found that models incorporating the P(nc) provided a better fit to the data set than the traditional (without risk) NB SPFs for total, injury and fatality (I+F) and property damage only (PDO) collisions. Copyright © 2011 Elsevier Ltd. All rights reserved.

Risk-Taking and the Adolescent Brain: Who Is at Risk?

ERIC Educational Resources Information Center

Galvan, Adriana; Hare, Todd; Voss, Henning; Glover, Gary; Casey, B. J.

2007-01-01

Relative to other ages, adolescence is described as a period of increased impulsive and risk-taking behavior that can lead to fatal outcomes (suicide, substance abuse, HIV, accidents, etc.). This study was designed to examine neural correlates of risk-taking behavior in adolescents, relative to children and adults, in order to predict who may be…

Sexual Victimization and Health-Risk Behaviors: A Prospective Analysis of College Women

ERIC Educational Resources Information Center

Gidycz, Christine A.; Orchowski, Lindsay M.; King, Carrie R.; Rich, Cindy L.

2008-01-01

The present study utilizes the National College Health Risk Behavior Survey to examine the relationship between health-risk behaviors and sexual victimization among a sample of college women. A prospective design is utilized to examine the relationship between health-risk behaviors as measured at baseline and sexual victimization during a 3-month…

How Engineers Really Think About Risk: A Study of JPL Engineers

NASA Technical Reports Server (NTRS)

Hihn, Jairus; Chattopadhyay, Deb; Valerdi, Ricardo

2011-01-01

The objectives of this work are: To improve risk assessment practices as used during the mission design process by JPL's concurrent engineering teams. (1) Developing effective ways to identify and assess mission risks (2) Providing a process for more effective dialog between stakeholders about the existence and severity of mission risks (3) Enabling the analysis of interactions of risks across concurrent engineering roles.

Heart Rate Reactivity during Contingency Learning in 5- to 10-Month-Old at-Risk and Non-Risk Babies

ERIC Educational Resources Information Center

Millar, W. S.; Weir, C. G.

2007-01-01

The study investigated the dynamic relation between contingency learning and heart rate with risk and non-risk babies 5- to 10-months-old. Four groups were compared in a two contingency treatments (contingent, yoked) x two risk status design. Concurrent heart rate was monitored during three phases of a contingency learning task (baseline,…

Bayesian analysis of time-series data under case-crossover designs: posterior equivalence and inference.

PubMed

Li, Shi; Mukherjee, Bhramar; Batterman, Stuart; Ghosh, Malay

2013-12-01

Case-crossover designs are widely used to study short-term exposure effects on the risk of acute adverse health events. While the frequentist literature on this topic is vast, there is no Bayesian work in this general area. The contribution of this paper is twofold. First, the paper establishes Bayesian equivalence results that require characterization of the set of priors under which the posterior distributions of the risk ratio parameters based on a case-crossover and time-series analysis are identical. Second, the paper studies inferential issues under case-crossover designs in a Bayesian framework. Traditionally, a conditional logistic regression is used for inference on risk-ratio parameters in case-crossover studies. We consider instead a more general full likelihood-based approach which makes less restrictive assumptions on the risk functions. Formulation of a full likelihood leads to growth in the number of parameters proportional to the sample size. We propose a semi-parametric Bayesian approach using a Dirichlet process prior to handle the random nuisance parameters that appear in a full likelihood formulation. We carry out a simulation study to compare the Bayesian methods based on full and conditional likelihood with the standard frequentist approaches for case-crossover and time-series analysis. The proposed methods are illustrated through the Detroit Asthma Morbidity, Air Quality and Traffic study, which examines the association between acute asthma risk and ambient air pollutant concentrations. © 2013, The International Biometric Society.

Consumption of fruit and vegetables reduces risk of pancreatic cancer: evidence from epidemiological studies.

PubMed

Wu, Qi-Jun; Wu, Lang; Zheng, Li-Qiang; Xu, Xin; Ji, Chao; Gong, Ting-Ting

2016-05-01

Observational studies have reported inconsistent results on the association between fruit and vegetable intake and the risk of pancreatic cancer. We carried out a meta-analysis of epidemiological studies to summarize available evidence. We searched PubMed, Scopus, and ISI Web of Science databases for relevant studies published until the end of January 2015. Fixed-effects and random-effects models were used to estimate the summary relative risks (RRs) and 95% confidence intervals (CIs) for the associations between fruit and vegetable intake and the risk of pancreatic cancer. A total of 15 case-control studies, eight prospective studies, and one pooled analysis fulfilled the inclusion criteria. The summary RR for the highest versus the lowest intake was 0.73 (95% CI=0.53-1.00) for fruit and vegetables, 0.73 (95% CI=0.63-0.84) for fruit, and 0.76 (95% CI=0.69-0.83) for vegetables, with significant heterogeneities (I=70.5, 55.7, and 43.0%, respectively). Inverse associations were observed in the stratified analysis by study design, although the results of prospective studies showed borderline significance, with corresponding RR=0.90 (95% CI=0.77-1.05) for fruit and vegetable intake, 0.93 (95% CI=0.83-1.03) for fruit intake, and 0.89 (95% CI=0.80-1.00) for vegetable intake. Besides, significant inverse associations were observed in the majority of other subgroup analyses by study quality, geographic location, exposure assessment method, and adjustment for potential confounders. Findings from the present meta-analysis support that fruit and vegetable intake is associated inversely with the risk of pancreatic cancer. However, study design may play a key role in the observed magnitude of the aforementioned association. Future well-designed prospective studies are warranted to confirm these findings.

Can Lifestyle Modification Improve Neurocognition? Rationale and Design of the ENLIGHTEN Clinical Trial

PubMed Central

Blumenthal, James A.; Smith, Patrick J.; Welsh-Bohmer, Kathleen; Babyak, Michael A.; Browndyke, Jeffrey; Lin, Pao-Hwa; Doraiswamy, P. Murali; Burke, James; Kraus, William; Hinderliter, Alan; Sherwood, Andrew

2013-01-01

Background Risk factors for cardiovascular disease (CVD) not only increase the risk for clinical CVD events, but also are associated with a cascade of neurophysiologic and neuroanatomic changes that increase the risk of cognitive impairment and dementia. Although epidemiological studies have shown that exercise and diet are associated with lower CVD risk and reduced incidence of dementia, no randomized controlled trial (RCT) has examined the independent effects of exercise and diet on neurocognitive function among individuals at risk for dementia. The ENLIGHTEN trial is a RCT of patients with CVD risk factors who also are characterized by subjective cognitive complaints and objective evidence of neurocognitive impairment without dementia (CIND) Study Design A 2 by 2 design will examine the independent and combined effects of diet and exercise on neurocognition. 160 participants diagnosed with CIND will be randomly assigned to 6 months of aerobic exercise, the DASH diet, or a combination of both exercise and diet; a (control) group will receive health education but otherwise will maintain their usual dietary and activity habits. Participants will complete comprehensive assessments of neurocognitive functioning along with biomarkers of CVD risk including measures of blood pressure, glucose, endothelial function, and arterial stiffness. Conclusion The ENLIGHTEN trial will (a) evaluate the effectiveness of aerobic exercise and the DASH diet in improving neurocognitive functioning in CIND patients with CVD risk factors; (b) examine possible mechanisms by which exercise and diet improve neurocognition; and (c) consider potential moderators of treatment, including subclinical CVD. PMID:23000080

Using an iPad® App to Improve Sight Word Reading Fluency for At-Risk First Graders

ERIC Educational Resources Information Center

Musti-Rao, Shobana; Lo, Ya-yu; Plati, Erin

2015-01-01

We used a multiple baseline across word lists design nested within a multiple baseline across participants design to examine the effects of instruction delivered using an iPad® app on sight word fluency and oral reading fluency of six first graders identified as at risk for reading failure. In Study 1, three students participated in…

Designing social marketing strategies to increase African Americans' access to health promotion programs.

PubMed

Icard, Larry D; Bourjolly, Joretha N; Siddiqui, Nushina

2003-08-01

This qualitative study explored four key factors--source, message, channel, and target--for linking at-risk African Americans with health promotion programs. Among the findings from focus group discussions was that the use of the African American church to involve at-risk African Americans in health promotion programs may actually function as a barrier for some individuals. The study also suggests that use of a high profile person to deliver a message may be counterproductive to efforts to motivate people to use health promotion programs. The significance of these and other findings for designing more effective social marketing strategies to increase at-risk African Americans' access to health promotion programs are discussed.

Coal gasification systems engineering and analysis, volume 2

NASA Technical Reports Server (NTRS)

1980-01-01

The major design related features of each generic plant system were characterized in a catalog. Based on the catalog and requirements data, approximately 17 designs and cost estimates were developed for MBG and alternate products. A series of generic trade studies was conducted to support all of the design studies. A set of cost and programmatic analyses were conducted to supplement the designs. The cost methodology employed for the design and sensitivity studies was documented and implemented in a computer program. Plant design and construction schedules were developed for the K-T, Texaco, and B&W MBG plant designs. A generic work breakdown structure was prepared, based on the K-T design, to coincide with TVA's planned management approach. An extensive set of cost sensitivity analyses was completed for K-T, Texaco, and B&W design. Product price competitiveness was evaluated for MBG and the alternate products. A draft management policy and procedures manual was evaluated. A supporting technology development plan was developed to address high technology risk issues. The issues were identified and ranked in terms of importance and tractability, and a plan developed for obtaining data or developing technology required to mitigate the risk.

Travel abroad increases sexual health risk-taking among Swedish youth: a population-based study using a case-crossover strategy

PubMed Central

Sundbeck, Mats; Agardh, Anette; Östergren, Per-Olof

2017-01-01

ABSTRACT Background: The fact that youth take sexual risks when they are abroad have been shown in previous studies. However, it is not known if they increased their sexual risk-taking when travelling abroad, compared to the stay in their homeland. Objective: To assess whether Swedish youth increased their individual sexual risk behaviour, defined as having a casual sex partner, when travelling abroad and to examine possible factors that may be associated with increased risk-taking abroad. Design: In 2013, a population-based sample of 2189 Swedes, 18-29 years, was assessed by a questionnaire (45% response rate). Sexuality, duration of travel, parents’ country of origin, mental health, heavy episodic drinking (HED), use of illicit drugs, and socio-demographic background were assessed. Increased risk of casual sex in relation to time spent abroad vs. time spent in Sweden was analysed by a variant of case-crossover design. Factors that could be associated with increased risk of casual sex in Sweden and abroad, separately, were analysed by logistic regression. PMID:28598729

Obesity and Cancer Risk

MedlinePlus

... cancer risk. Despite the limitations of the study designs, there is consistent evidence that higher amounts of ... the National Cancer Institute.” Please note that blog posts that are written by individuals from outside the ...

A Holistic Approach for Risk Management During Design

NASA Technical Reports Server (NTRS)

Meshkat, Leila

2006-01-01

In this paper, an approach for the identification, assessment, mitigation and continuous management of risks during the process of designing a space mission is presented. This approach has been developed by observing the risk patterns that occur at the Project Design Center of the Jet Propulsion Laboratory (TeamX) which develops conceptual, concurrent design of Space Missions. TeamX develops an end-to-end conceptual design of a Space Mission in a matter of one or two weeks. As the risk chair in TeamX, the author has had the opportunity to observe the risk patterns that occur during design over the course of many design sessions. This paper introduces an abstraction and generalization of those patterns. Risk is defined as anything that can go wrong, along with its approximate likelihood and consequence. The indicators, and causes, and effects of these risks are cross cutting across the multiple levels of people and processes involved in the design, and the actual design product itself.

Probability of Loss of Crew Achievability Studies for NASA's Exploration Systems Development

NASA Technical Reports Server (NTRS)

Boyer, Roger L.; Bigler, Mark; Rogers, James H.

2014-01-01

Over the last few years, NASA has been evaluating various vehicle designs for multiple proposed design reference missions (DRM) beyond low Earth orbit in support of its Exploration Systems Development (ESD) programs. This paper addresses several of the proposed missions and the analysis techniques used to assess the key risk metric, probability of loss of crew (LOC). Probability of LOC is a metric used to assess the safety risk as well as a design requirement. These risk assessments typically cover the concept phase of a DRM, i.e. when little more than a general idea of the mission is known and are used to help establish "best estimates" for proposed program and agency level risk requirements. These assessments or studies were categorized as LOC achievability studies to help inform NASA management as to what "ball park" estimates of probability of LOC could be achieved for each DRM and were eventually used to establish the corresponding LOC requirements. Given that details of the vehicles and mission are not well known at this time, the ground rules, assumptions, and consistency across the programs become the important basis of the assessments as well as for the decision makers to understand.

Probability of Loss of Crew Achievability Studies for NASA's Exploration Systems Development

NASA Technical Reports Server (NTRS)

Boyer, Roger L.; Bigler, Mark; Rogers, James H.

2015-01-01

Over the last few years, NASA has been evaluating various vehicle designs for multiple proposed design reference missions (DRM) beyond low Earth orbit in support of its Exploration Systems Development (ESD) programs. This paper addresses several of the proposed missions and the analysis techniques used to assess the key risk metric, probability of loss of crew (LOC). Probability of LOC is a metric used to assess the safety risk as well as a design requirement. These risk assessments typically cover the concept phase of a DRM, i.e. when little more than a general idea of the mission is known and are used to help establish "best estimates" for proposed program and agency level risk requirements. These assessments or studies were categorized as LOC achievability studies to help inform NASA management as to what "ball park" estimates of probability of LOC could be achieved for each DRM and were eventually used to establish the corresponding LOC requirements. Given that details of the vehicles and mission are not well known at this time, the ground rules, assumptions, and consistency across the programs become the important basis of the assessments as well as for the decision makers to understand.

Dairy consumption, systolic blood pressure, and risk of hypertension: Mendelian randomization study

USDA-ARS?s Scientific Manuscript database

Objective: To examine whether previous observed inverse associations of dairy intake with systolic blood pressure and risk of hypertension were causal. Design: Mendelian randomization study using the single nucleotide polymorphism rs4988235 related to lactase persistence as an instrumental variable...

Does design matter? Systematic evaluation of the impact of analytical choices on effect estimates in observational studies

PubMed Central

Ryan, Patrick B.; Schuemie, Martijn

2013-01-01

Background: Clinical studies that use observational databases, such as administrative claims and electronic health records, to evaluate the effects of medical products have become commonplace. These studies begin by selecting a particular study design, such as a case control, cohort, or self-controlled design, and different authors can and do choose different designs for the same clinical question. Furthermore, published papers invariably report the study design but do not discuss the rationale for the specific choice. Studies of the same clinical question with different designs, however, can generate different results, sometimes with strikingly different implications. Even within a specific study design, authors make many different analytic choices and these too can profoundly impact results. In this paper, we systematically study heterogeneity due to the type of study design and due to analytic choices within study design. Methods and findings: We conducted our analysis in 10 observational healthcare databases but mostly present our results in the context of the GE Centricity EMR database, an electronic health record database containing data for 11.2 million lives. We considered the impact of three different study design choices on estimates of associations between bisphosphonates and four particular health outcomes for which there is no evidence of an association. We show that applying alternative study designs can yield discrepant results, in terms of direction and significance of association. We also highlight that while traditional univariate sensitivity analysis may not show substantial variation, systematic assessment of all analytical choices within a study design can yield inconsistent results ranging from statistically significant decreased risk to statistically significant increased risk. Our findings show that clinical studies using observational databases can be sensitive both to study design choices and to specific analytic choices within study design. Conclusion: More attention is needed to consider how design choices may be impacting results and, when possible, investigators should examine a wide array of possible choices to confirm that significant findings are consistently identified. PMID:25083251

Work Related Psychosocial and Organizational Factors for Neck Pain in Workers in the United States

PubMed Central

Yang, Haiou; Hitchcock, Edward; Haldeman, Scott; Swanson, Naomi; Lu, Ming-Lun; Choi, BongKyoo; Nakata, Akinori; Baker, Dean

2016-01-01

Background Neck pain is a prevalent musculoskeletal condition among workers in the United States. This study explores a set of workplace psychosocial and organization-related factors for neck pain. Methods Data used for this study comes from the 2010 National Health interview Survey which provides a representative sample of the US population. To account for the complex sampling design, the Taylor linearized variance estimation method was used. Logistic regression models were constructed to measure the associations. Results This study demonstrated significant associations between neck pain and a set of workplace risk factors including work-family imbalance, exposure to a hostile work environment and job insecurity, non-standard work arrangements, multiple jobs and long work hours. Conclusion Workers with neck pain may benefit from intervention programs that address issues related to these workplace risk factors. Future studies exploring both psychosocial risk factors and physical risk factors with a longitudinal design will be important. PMID:27184340

Workplace psychosocial and organizational factors for neck pain in workers in the United States.

PubMed

Yang, Haiou; Hitchcock, Edward; Haldeman, Scott; Swanson, Naomi; Lu, Ming-Lun; Choi, BongKyoo; Nakata, Akinori; Baker, Dean

2016-07-01

Neck pain is a prevalent musculoskeletal condition among workers in the United States. This study explores a set of workplace psychosocial and organization-related factors for neck pain. Data used for this study come from the 2010 National Health Interview Survey which provides a representative sample of the US population. To account for the complex sampling design, the Taylor linearized variance estimation method was used. Logistic regression models were constructed to measure the associations. This study demonstrated significant associations between neck pain and a set of workplace risk factors, including work-family imbalance, exposure to a hostile work environment and job insecurity, non-standard work arrangements, multiple jobs, and long work hours. Workers with neck pain may benefit from intervention programs that address issues related to these workplace risk factors. Future studies exploring both psychosocial risk factors and physical risk factors with a longitudinal design will be important. Am. J. Ind. Med. 59:549-560, 2016. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

Cost and Economics for Advanced Launch Vehicles

NASA Technical Reports Server (NTRS)

Whitfield, Jeff

1998-01-01

Market sensitivity and weight-based cost estimating relationships are key drivers in determining the financial viability of advanced space launch vehicle designs. Due to decreasing space transportation budgets and increasing foreign competition, it has become essential for financial assessments of prospective launch vehicles to be performed during the conceptual design phase. As part of this financial assessment, it is imperative to understand the relationship between market volatility, the uncertainty of weight estimates, and the economic viability of an advanced space launch vehicle program. This paper reports the results of a study that evaluated the economic risk inherent in market variability and the uncertainty of developing weight estimates for an advanced space launch vehicle program. The purpose of this study was to determine the sensitivity of a business case for advanced space flight design with respect to the changing nature of market conditions and the complexity of determining accurate weight estimations during the conceptual design phase. The expected uncertainty associated with these two factors drives the economic risk of the overall program. The study incorporates Monte Carlo simulation techniques to determine the probability of attaining specific levels of economic performance when the market and weight parameters are allowed to vary. This structured approach toward uncertainties allows for the assessment of risks associated with a launch vehicle program's economic performance. This results in the determination of the value of the additional risk placed on the project by these two factors.

Quality-by-Design II: Application of Quantitative Risk Analysis to the Formulation of Ciprofloxacin Tablets.

PubMed

Claycamp, H Gregg; Kona, Ravikanth; Fahmy, Raafat; Hoag, Stephen W

2016-04-01

Qualitative risk assessment methods are often used as the first step to determining design space boundaries; however, quantitative assessments of risk with respect to the design space, i.e., calculating the probability of failure for a given severity, are needed to fully characterize design space boundaries. Quantitative risk assessment methods in design and operational spaces are a significant aid to evaluating proposed design space boundaries. The goal of this paper is to demonstrate a relatively simple strategy for design space definition using a simplified Bayesian Monte Carlo simulation. This paper builds on a previous paper that used failure mode and effects analysis (FMEA) qualitative risk assessment and Plackett-Burman design of experiments to identity the critical quality attributes. The results show that the sequential use of qualitative and quantitative risk assessments can focus the design of experiments on a reduced set of critical material and process parameters that determine a robust design space under conditions of limited laboratory experimentation. This approach provides a strategy by which the degree of risk associated with each known parameter can be calculated and allocates resources in a manner that manages risk to an acceptable level.

How young people communicate risks of snowmobiling in northern Norway: a focus group study.

PubMed

Mehus, Grete; Germeten, Sidsel; Henriksen, Nils

2011-04-01

This study aims to understand how the risks of snowmobiling are communicated among northern Norwegian youths. Study design. A qualitative design with focus group interviews was chosen. Interviews centred on safety precautions and estimation of risks related to snowmobiling and driving patterns. Eighty-one students (31 girls and 50 boys) aged between 16 and 23 years from 8 high schools were interviewed in 17 focus groups that were segregated by gender. Interview data were analysed using qualitative content analysis. Boys and girls communicated differently about risks. Peer-group conformity appeared stronger among boys than girls. Boys did not spontaneously relate risks to their snowmobile activities, while girls did. Boys focused upon training, coping and balance between control and lack of control while driving. Girls talked about risks, were aware of risks and sought to avoid risky situations, in contrast to boys. Boys' risk communication in groups was about how to manage challenging situations. Their focus overall was on trying to maintain control while simultaneously testing their limits. Three risk categories emerged: those who drive as they ought to (mostly girls), those who occasionally take some risks (boys and girls) and those who are extreme risk-takers (a smaller number of boys). Perceptions of and communication about risk are related to gender, peer group and familiarity with risk-taking when snowmobiling. Northern Norwegian boys' driving behaviour highlights a specific need for risk reduction, but this must also draw upon factors such as acceptance of social and cultural codes and common sense related to snowmobiling.

Lift/cruise fan V/STOL technology aircraft design definition study. Volume 2: Propulsion transmission system design

NASA Technical Reports Server (NTRS)

Obrien, W. J.

1976-01-01

Two types of lift/cruise fan technology aircraft were conceptually designed. One aircraft used turbotip fans pneumatically interconnected to three gas generators, and the other aircraft used variable pitch fans mechanically interconnected to three turboshaft engines. The components of each propulsion transmission system were analyzed and designed to the depth necessary to determine areas of risk, development methods, performance, weights and costs. The types of materials and manufacturing processes were identified to show that the designs followed a low cost approach. The lift/cruise fan thrust vectoring hoods, which are applicable to either aircraft configuration, were also evaluated to assure a low cost/low risk approach.

The Role of DNA Methylation in Cardiovascular Risk and Disease: Methodological Aspects, Study Design, and Data Analysis for Epidemiological Studies.

PubMed

Zhong, Jia; Agha, Golareh; Baccarelli, Andrea A

2016-01-08

Epidemiological studies have demonstrated that genetic, environmental, behavioral, and clinical factors contribute to cardiovascular disease development. How these risk factors interact at the cellular level to cause cardiovascular disease is not well known. Epigenetic epidemiology enables researchers to explore critical links between genomic coding, modifiable exposures, and manifestation of disease phenotype. One epigenetic link, DNA methylation, is potentially an important mechanism underlying these associations. In the past decade, there has been a significant increase in the number of epidemiological studies investigating cardiovascular risk factors and outcomes in relation to DNA methylation, but many gaps remain in our understanding of the underlying cause and biological implications. In this review, we provide a brief overview of the biology and mechanisms of DNA methylation and its role in cardiovascular disease. In addition, we summarize the current evidence base in epigenetic epidemiology studies relevant to cardiovascular health and disease and discuss the limitations, challenges, and future directions of the field. Finally, we provide guidelines for well-designed epigenetic epidemiology studies, with particular focus on methodological aspects, study design, and analytical challenges. © 2016 American Heart Association, Inc.

Reducing 30-Day Readmission Rates in a High-Risk Population Using a Lay-Health Worker Model in Appalachia Kentucky

ERIC Educational Resources Information Center

Cardarelli, Roberto; Horsley, Mary; Ray, Lisa; Maggard, Nancy; Schilling, Jennifer; Weatherford, Sarah; Feltner, Fran; Gilliam, Kayla

2018-01-01

This exploratory study aimed to address the effectiveness of a lay-health worker (LHW) model in addressing social needs and readmissions of high-risk patients admitted in a rural community hospital. A quasi-experimental study design assessed implementation of a LHW model for assisting high-risk patients with their post-discharge social needs.…

Special Diabetes Program for Indians: Retention in Cardiovascular Risk Reduction

ERIC Educational Resources Information Center

Manson, Spero M.; Jiang, Luohua; Zhang, Lijing; Beals, Janette; Acton, Kelly J.; Roubideaux, Yvette

2011-01-01

Purpose: This study examined the associations between participant and site characteristics and retention in a multisite cardiovascular disease risk reduction project. Design and Methods: Data were derived from the Special Diabetes Program for Indians Healthy Heart Demonstration Project, an intervention to reduce cardiovascular risk among American…

Observational methods to assess the effectiveness of screening colonoscopy in reducing right colon cancer mortality risk: SCOLAR.

PubMed

Goodman, Michael; Fletcher, Robert H; Doria-Rose, V Paul; Jensen, Christopher D; Zebrowski, Alexis M; Becerra, Tracy A; Quinn, Virginia P; Zauber, Ann G; Corley, Douglas A; Doubeni, Chyke A

2015-11-01

Screening colonoscopy's effectiveness in reducing risk of death from right colon cancers remains unclear. Methodological challenges of existing observational studies addressing this issue motivated the design of 'Effectiveness of Screening for Colorectal Cancer in Average-Risk Adults (SCOLAR)'. SCOLAR is a nested case-control study based on two large integrated health systems. This affords access to a large, well-defined historical cohort linked to integrated data on cancer outcomes, patient eligibility, test indications and important confounders. We found electronic data adequate for excluding ineligible patients (except family history), but not the detailed information needed for test indication assignment. The lessons of SCOLAR's design and implementation may be useful for future studies seeking to evaluate the effectiveness of screening tests in community settings.

SEMIPARAMETRIC ADDITIVE RISKS REGRESSION FOR TWO-STAGE DESIGN SURVIVAL STUDIES

PubMed Central

Li, Gang; Wu, Tong Tong

2011-01-01

In this article we study a semiparametric additive risks model (McKeague and Sasieni (1994)) for two-stage design survival data where accurate information is available only on second stage subjects, a subset of the first stage study. We derive two-stage estimators by combining data from both stages. Large sample inferences are developed. As a by-product, we also obtain asymptotic properties of the single stage estimators of McKeague and Sasieni (1994) when the semiparametric additive risks model is misspecified. The proposed two-stage estimators are shown to be asymptotically more efficient than the second stage estimators. They also demonstrate smaller bias and variance for finite samples. The developed methods are illustrated using small intestine cancer data from the SEER (Surveillance, Epidemiology, and End Results) Program. PMID:21931467

Searching for non-genetic molecular and imaging PTSD risk and resilience markers: Systematic review of literature and design of the German Armed Forces PTSD biomarker study.

PubMed

Schmidt, Ulrike; Willmund, Gerd-Dieter; Holsboer, Florian; Wotjak, Carsten T; Gallinat, Jürgen; Kowalski, Jens T; Zimmermann, Peter

2015-01-01

Biomarkers allowing the identification of individuals with an above average vulnerability or resilience for posttraumatic stress disorder (PTSD) would especially serve populations at high risk for trauma exposure like firefighters, police officers and combat soldiers. Aiming to identify the most promising putative PTSD vulnerability markers, we conducted the first systematic review on potential imaging and non-genetic molecular markers for PTSD risk and resilience. Following the PRISMA guidelines, we systematically screened the PubMed database for prospective longitudinal clinical studies and twin studies reporting on pre-trauma and post-trauma PTSD risk and resilience biomarkers. Using 25 different combinations of search terms, we retrieved 8151 articles of which we finally included and evaluated 9 imaging and 27 molecular studies. In addition, we briefly illustrate the design of the ongoing prospective German Armed Forces (Bundeswehr) PTSD biomarker study (Bw-BioPTSD) which not only aims to validate these previous findings but also to identify novel and clinically applicable molecular, psychological and imaging risk, resilience and disease markers for deployment-related psychopathology in a cohort of German soldiers who served in Afghanistan. Copyright © 2014 Elsevier Ltd. All rights reserved.

How are lung cancer risk perceptions and cigarette smoking related?-testing an accuracy hypothesis.

PubMed

Chen, Lei-Shih; Kaphingst, Kimberly A; Tseng, Tung-Sung; Zhao, Shixi

2016-10-01

Subjective risk perception is an important theoretical construct in the field of cancer prevention and control. Although the relationship between subjective risk perception and health behaviors has been widely studied in many health contexts, the causalities and associations between the risk perception of developing lung cancer and cigarette smoking have been inconsistently reported among studies. Such inconsistency may be from discrepancies between study designs (cross-sectional versus longitudinal designs) and the three hypotheses (i.e., the behavior motivation hypothesis, the risk reappraisals hypothesis, and the accuracy hypothesis) testing different underlying associations between risk perception and cigarette-smoking behaviors. To clarify this issue, as an initial step, we examined the association between absolute and relative risk perceptions of developing lung cancer and cigarette-smoking behaviors among a large, national representative sample of 1,680 U.S. adults by testing an accuracy hypothesis (i.e., people who smoke accurately perceived a higher risk of developing lung cancer). Data from the U.S. Health Information National Trends Survey (HINTS) were analyzed using logistic regression and multivariate linear regression to examine the associations between risk perception and cigarette-smoking behaviors among 1,680 U.S. adults. Findings from this cross-sectional survey suggest that absolute and relative risk perceptions were positively and significantly correlated with having smoked >100 cigarettes during lifetime and the frequency of cigarette smoking. Only absolute risk perception was significantly associated with the number of cigarettes smoked per day among current smokers. Because both absolute and relative risk perceptions are positively related to most cigarette-smoking behaviors, this study supports the accuracy hypothesis. Moreover, absolute risk perception might be a more sensitive measurement than relative risk perception for perceived lung cancer risk. Longitudinal research is needed in the future to investigate other types of risk perception-risk behavior hypotheses-the behavior motivation and the risk reappraisals hypotheses-among nationally representative samples to further examine the causations between risk perception of obtaining lung cancer and smoking behaviors.

Reliability and Probabilistic Risk Assessment - How They Play Together

NASA Technical Reports Server (NTRS)

Safie, Fayssal M.; Stutts, Richard G.; Zhaofeng, Huang

2015-01-01

PRA methodology is one of the probabilistic analysis methods that NASA brought from the nuclear industry to assess the risk of LOM, LOV and LOC for launch vehicles. PRA is a system scenario based risk assessment that uses a combination of fault trees, event trees, event sequence diagrams, and probability and statistical data to analyze the risk of a system, a process, or an activity. It is a process designed to answer three basic questions: What can go wrong? How likely is it? What is the severity of the degradation? Since 1986, NASA, along with industry partners, has conducted a number of PRA studies to predict the overall launch vehicles risks. Planning Research Corporation conducted the first of these studies in 1988. In 1995, Science Applications International Corporation (SAIC) conducted a comprehensive PRA study. In July 1996, NASA conducted a two-year study (October 1996 - September 1998) to develop a model that provided the overall Space Shuttle risk and estimates of risk changes due to proposed Space Shuttle upgrades. After the Columbia accident, NASA conducted a PRA on the Shuttle External Tank (ET) foam. This study was the most focused and extensive risk assessment that NASA has conducted in recent years. It used a dynamic, physics-based, integrated system analysis approach to understand the integrated system risk due to ET foam loss in flight. Most recently, a PRA for Ares I launch vehicle has been performed in support of the Constellation program. Reliability, on the other hand, addresses the loss of functions. In a broader sense, reliability engineering is a discipline that involves the application of engineering principles to the design and processing of products, both hardware and software, for meeting product reliability requirements or goals. It is a very broad design-support discipline. It has important interfaces with many other engineering disciplines. Reliability as a figure of merit (i.e. the metric) is the probability that an item will perform its intended function(s) for a specified mission profile. In general, the reliability metric can be calculated through the analyses using reliability demonstration and reliability prediction methodologies. Reliability analysis is very critical for understanding component failure mechanisms and in identifying reliability critical design and process drivers. The following sections discuss the PRA process and reliability engineering in detail and provide an application where reliability analysis and PRA were jointly used in a complementary manner to support a Space Shuttle flight risk assessment.

Priority issues, study designs and geographical distribution in nutrition journals.

PubMed

Ortiz-Moncada, R; González-Zapata, L; Ruiz-Cantero, M T; Clemente-Gómez, V

2011-01-01

The increased number of articles published in nutrition is a reflection of the relevance to scientific community. The characteristics and quality of nutritional studies determine whether readers can obtain valid conclusions from them, as well as their usefulness for evidence-based strategic policies. To determine the characteristics of papers published in nutrition journals. Descriptive study design. We reviewed 330 original papers published between January-June 2007. From: American Journal of Clinical Nutrition (AJCN), Journal of Nutrition, European Journal Nutrition, European Journal of Clinical Nutrition and Public Health Nutrition. We classified them according to the subjects studied; risk factors, study design and country of origin. Almost half the papers studied healthy people (53.3%). The most frequent illness was obesity (13.9%). Food consumption is the most frequent risk factor (63.3%). Social factors appear exclusively only in 3.6% of the papers. Clinical trials were the most common analytical design (31.8%), mainly in the AJCN (45.6%). Cross-sectional studies were the most frequent type of observational design (37.9%). Ten countries produced over half of the papers (51.3%). The US publishes the highest number of papers (20.6%), whilst developing countries make only scarce contributions to scientific literature on nutrition. Most of the papers had inferential power. They generally studied both healthy and sick subjects, coinciding with the aims of international scientific policies. However, the topics covered reflect a clear bias, prioritizing problems pertaining to developed countries. Social determinants of health should also be considered, along with behavioral and biological risk factors.

Healthcare outcomes assessed with observational study designs compared with those assessed in randomized trials.

PubMed

Anglemyer, Andrew; Horvath, Hacsi T; Bero, Lisa

2014-04-29

Researchers and organizations often use evidence from randomized controlled trials (RCTs) to determine the efficacy of a treatment or intervention under ideal conditions. Studies of observational designs are often used to measure the effectiveness of an intervention in 'real world' scenarios. Numerous study designs and modifications of existing designs, including both randomized and observational, are used for comparative effectiveness research in an attempt to give an unbiased estimate of whether one treatment is more effective or safer than another for a particular population.A systematic analysis of study design features, risk of bias, parameter interpretation, and effect size for all types of randomized and non-experimental observational studies is needed to identify specific differences in design types and potential biases. This review summarizes the results of methodological reviews that compare the outcomes of observational studies with randomized trials addressing the same question, as well as methodological reviews that compare the outcomes of different types of observational studies. To assess the impact of study design (including RCTs versus observational study designs) on the effect measures estimated.To explore methodological variables that might explain any differences identified.To identify gaps in the existing research comparing study designs. We searched seven electronic databases, from January 1990 to December 2013.Along with MeSH terms and relevant keywords, we used the sensitivity-specificity balanced version of a validated strategy to identify reviews in PubMed, augmented with one term ("review" in article titles) so that it better targeted narrative reviews. No language restrictions were applied. We examined systematic reviews that were designed as methodological reviews to compare quantitative effect size estimates measuring efficacy or effectiveness of interventions tested in trials with those tested in observational studies. Comparisons included RCTs versus observational studies (including retrospective cohorts, prospective cohorts, case-control designs, and cross-sectional designs). Reviews were not eligible if they compared randomized trials with other studies that had used some form of concurrent allocation. In general, outcome measures included relative risks or rate ratios (RR), odds ratios (OR), hazard ratios (HR). Using results from observational studies as the reference group, we examined the published estimates to see whether there was a relative larger or smaller effect in the ratio of odds ratios (ROR).Within each identified review, if an estimate comparing results from observational studies with RCTs was not provided, we pooled the estimates for observational studies and RCTs. Then, we estimated the ratio of ratios (risk ratio or odds ratio) for each identified review using observational studies as the reference category. Across all reviews, we synthesized these ratios to get a pooled ROR comparing results from RCTs with results from observational studies. Our initial search yielded 4406 unique references. Fifteen reviews met our inclusion criteria; 14 of which were included in the quantitative analysis.The included reviews analyzed data from 1583 meta-analyses that covered 228 different medical conditions. The mean number of included studies per paper was 178 (range 19 to 530).Eleven (73%) reviews had low risk of bias for explicit criteria for study selection, nine (60%) were low risk of bias for investigators' agreement for study selection, five (33%) included a complete sample of studies, seven (47%) assessed the risk of bias of their included studies,Seven (47%) reviews controlled for methodological differences between studies,Eight (53%) reviews controlled for heterogeneity among studies, nine (60%) analyzed similar outcome measures, and four (27%) were judged to be at low risk of reporting bias.Our primary quantitative analysis, including 14 reviews, showed that the pooled ROR comparing effects from RCTs with effects from observational studies was 1.08 (95% confidence interval (CI) 0.96 to 1.22). Of 14 reviews included in this analysis, 11 (79%) found no significant difference between observational studies and RCTs. One review suggested observational studies had larger effects of interest, and two reviews suggested observational studies had smaller effects of interest.Similar to the effect across all included reviews, effects from reviews comparing RCTs with cohort studies had a pooled ROR of 1.04 (95% CI 0.89 to 1.21), with substantial heterogeneity (I(2) = 68%). Three reviews compared effects of RCTs and case-control designs (pooled ROR: 1.11 (95% CI 0.91 to 1.35)).No significant difference in point estimates across heterogeneity, pharmacological intervention, or propensity score adjustment subgroups were noted. No reviews had compared RCTs with observational studies that used two of the most common causal inference methods, instrumental variables and marginal structural models. Our results across all reviews (pooled ROR 1.08) are very similar to results reported by similarly conducted reviews. As such, we have reached similar conclusions; on average, there is little evidence for significant effect estimate differences between observational studies and RCTs, regardless of specific observational study design, heterogeneity, or inclusion of studies of pharmacological interventions. Factors other than study design per se need to be considered when exploring reasons for a lack of agreement between results of RCTs and observational studies. Our results underscore that it is important for review authors to consider not only study design, but the level of heterogeneity in meta-analyses of RCTs or observational studies. A better understanding of how these factors influence study effects might yield estimates reflective of true effectiveness.

Is the exposure to antidepressant drugs in early pregnancy a risk factor for spontaneous abortion? A review of available evidences.

PubMed

Santone, Giovanni; Ricchi, Gianmatteo; Rocchetti, David; Tofani, Stefania; Bellantuono, Cesario

2009-01-01

To review studies conducted to establish the risk of spontaneous abortion (SA) in women exposed to antidepressant drugs (ADs) during early pregnancy. By using different search terms, PubMed, Toxline, EMBASE, PsychINFO, and the Cochrane library databases were searched from January 1980 to March 2008, to identify studies assessing the risk of SA in women exposed to different classes of ADs during the first trimester of pregnancy. Ten studies over 21 identified were selected for the analysis. All were performed prospectively and included as control group unexposed women, or exposed to non-teratogenic drugs or to placebo. In seven studies a depressive episode was specified as the reason for which the drug was prescribed, while the time of exposure was in nine. Only three studies over ten selected reported a significant association between an increased rate of SAs and early pregnancy exposure to some ADs. Many methodological flaws in the study design were found in all studies considered. Given this background and a lack of strong evidence on this issue, further prospective and better designed studies are needed to assess the risk of SA in pregnant women exposed to ADs against the risk of an untreated maternal depression.

Research design considerations for clinical studies of abuse-deterrent opioid analgesics: IMMPACT recommendations

PubMed Central

Turk, Dennis C.; O’Connor, Alec B.; Dworkin, Robert H.; Chaudhry, Amina; Katz, Nathaniel P.; Adams, Edgar H.; Brownstein, John S.; Comer, Sandra D.; Dart, Richard; Dasgupta, Nabarun; Denisco, Richard A.; Klein, Michael; Leiderman, Deborah B.; Lubran, Robert; Rappaport, Bob A.; Zacny, James P.; Ahdieh, Harry; Burke, Laurie B.; Cowan, Penney; Jacobs, Petra; Malamut, Richard; Markman, John; Michna, Edward; Palmer, Pamela; Peirce-Sandner, Sarah; Potter, Jennifer S.; Raja, Srinivasa N.; Rauschkolb, Christine; Roland, Carl L.; Webster, Lynn R.; Weiss, Roger D.; Wolf, Kerry

2013-01-01

Opioids are essential to the management of pain in many patients, but they also are associated with potential risks for abuse, overdose, and diversion. A number of efforts have been devoted to the development of abuse-deterrent formulations of opioids to reduce these risks. This article summarizes a consensus meeting that was organized to propose recommendations for the types of clinical studies that can be used to assess the abuse deterrence of different opioid formulations. Due to the many types of individuals who may be exposed to opioids, an opioid formulation will need to be studied in several populations using various study designs in order to determine its abuse-deterrent capabilities. It is recommended that the research conducted to evaluate abuse deterrence should include studies assessing: (1) abuse liability; (2) the likelihood that opioid abusers will find methods to circumvent the deterrent properties of the formulation; (3) measures of misuse and abuse in randomized clinical trials involving pain patients with both low risk and high risk of abuse; and (4) post-marketing epidemiological studies. PMID:22770841

Design and Cohort Characteristics of the Social Spectrum Study: A Multicenter Study of the Autism Spectrum among Clinically Referred Children

ERIC Educational Resources Information Center

Duvekot, Jorieke; Hoopen, Leontine W.; Slappendel, Geerte; van der Ende, Jan; Verhulst, Frank C.; van der Sijde, Ad; Greaves-Lord, Kirstin

2017-01-01

This paper provides an overview of the design and cohort characteristics of the Social Spectrum Study: a clinical cohort study that used a two-phase sampling design to identify children at risk for ASD. After screening 1281 children aged 2.5-10 years who had been consecutively referred to one of six mental health services in the Netherlands,…

School Counsellors' Perceptions on Working with Student High-Risk Behaviour

ERIC Educational Resources Information Center

Harris, Gregory E.; Jeffery, Gary

2010-01-01

The current exploratory-descriptive study used a survey design method to examine guidance counsellors' and educational psychologists' perceptions of their preparation, motivation, and effectiveness in preventing, assessing, and intervening into student high-risk behaviour. The study also explored training associated with addressing high-risk…

Emotion Recognition in Fathers and Mothers at High-Risk for Child Physical Abuse

ERIC Educational Resources Information Center

Asla, Nagore; de Paul, Joaquin; Perez-Albeniz, Alicia

2011-01-01

Objective: The present study was designed to determine whether parents at high risk for physical child abuse, in comparison with parents at low risk, show deficits in emotion recognition, as well as to examine the moderator effect of gender and stress on the relationship between risk for physical child abuse and emotion recognition. Methods: Based…

Comparing Growth Trajectories of Risk Behaviors from Late Adolescence through Young Adulthood: An Accelerated Design

ERIC Educational Resources Information Center

Brodbeck, Jeannette; Bachmann, Monica S.; Croudace, Tim J.; Brown, Anna

2013-01-01

Risk behaviors such as substance use or deviance are often limited to the early stages of the life course. Whereas the onset of risk behavior is well studied, less is currently known about the decline and timing of cessation of risk behaviors of different domains during young adulthood. Prevalence and longitudinal developmental patterning of…

Integrated Application of Quality-by-Design Principles to Drug Product Development: A Case Study of Brivanib Alaninate Film-Coated Tablets.

PubMed

Badawy, Sherif I F; Narang, Ajit S; LaMarche, Keirnan R; Subramanian, Ganeshkumar A; Varia, Sailesh A; Lin, Judy; Stevens, Tim; Shah, Pankaj A

2016-01-01

Modern drug product development is expected to follow quality-by-design (QbD) paradigm. At the same time, although there are several issue-specific examples in the literature that demonstrate the application of QbD principles, a holistic demonstration of the application of QbD principles to drug product development and control strategy, is lacking. This article provides an integrated case study on the systematic application of QbD to product development and demonstrates the implementation of QbD concepts in the different aspects of product and process design for brivanib alaninate film-coated tablets. Using a risk-based approach, the strategy for development entailed identification of product critical quality attributes (CQAs), assessment of risks to the CQAs, and performing experiments to understand and mitigate identified risks. Quality risk assessments and design of experiments were performed to understand the quality of the input raw materials required for a robust formulation and the impact of manufacturing process parameters on CQAs. In addition to the material property and process parameter controls, the proposed control strategy includes use of process analytical technology and conventional analytical tests to control in-process material attributes and ensure quality of the final product. Copyright © 2016. Published by Elsevier Inc.

Chronic health problems and risk of accidental injury in the workplace: A systematic literature review

PubMed Central

PALMER, K T; HARRIS, E C; COGGON, D

2013-01-01

Objectives To investigate whether common important health conditions and their treatments increase risks of occupational injury. Methods A systematic search was conducted of Medline, Embase and PsycINFO databases from inception to November 2006 employing terms for occupational injury, medications, and a broad range of diseases and impairments. Papers related solely to driving, alcohol, or substance abuse were excluded, as were studies that did not allow analysis of injury risk. For each paper that was retrieved we abstracted standard information on the population, design, exposure(s), outcome(s), response rates, confounders and effect estimates; and rated the quality of information provided. Results We found 38 relevant papers (33 study populations): 16 studies were of cross-sectional design, 13 were case-control and four were prospective. The overall quality was rated as excellent for only two studies. Most commonly investigated were problems of hearing (15 studies), mental health (11 studies) and vision (10 studies). For impaired hearing, neurotic illness, diabetes, epilepsy and use of sedating medication there were moderate positive associations with occupational injury (ORs 1.5–2.0), but there were major gaps in the evidence base. Studies on vision did not present risks by category of eye disease; no evidence was found on psychotic illness; for diabetes, epilepsy and cardiovascular disease there were remarkably few papers; studies seldom distinguished risks by sub-category of external cause or anatomical site and nature of injury; and exposures and outcomes were mostly ascertained by self-report at a single time point, with a lack of clarity about exposure timings. Conclusion Improved research is needed to define the risks of occupational injury arising from common health complaints and treatments. Such research should delineate exposures and outcomes in more detail, and ensure by design that the former precede the latter. PMID:18417559

Effects of imperfect test sensitivity and specificity on observational studies of influenza vaccine effectiveness.

PubMed

Jackson, Michael L; Rothman, Kenneth J

2015-03-10

The recently developed test-negative design is now standard for observational studies of influenza vaccine effectiveness (VE). It is unclear how influenza test misclassification biases test-negative VE estimates relative to VE estimates from traditional cohort or case-control studies. We simulated populations whose members may develop acute respiratory illness (ARI) due to influenza and to non-influenza pathogens. In these simulations, vaccination reduces the risk of influenza but not of non-influenza ARI. Influenza test sensitivity and specificity, risks of influenza and non-influenza ARI, and VE were varied across the simulations. In each simulation, we estimated influenza VE using a cohort design, a case-control design, and a test-negative design. In the absence of influenza test misclassification, all three designs accurately estimated influenza VE. In the presence of misclassification, all three designs underestimated VE. Bias in VE estimates was slightly greater in the test-negative design than in cohort or case-control designs. Assuming the use of highly sensitive and specific reverse-transcriptase polymerase chain reaction tests for influenza, bias in the test-negative studies was trivial across a wide range of realistic values for VE. Although influenza test misclassification causes more bias in test-negative studies than in traditional cohort or case-control studies, the difference is trivial for realistic combinations of attack rates, test sensitivity/specificity, and VE. Copyright © 2015 Elsevier Ltd. All rights reserved.

Risk factors associated with asbestos-related diseases: a community-based case–control study

PubMed Central

2013-01-01

Background Asbestos is a first level carcinogen. However, few epidemiological studies analyse the risk and protective factors associated with asbestos-related diseases and follow up these conditions in the general population. Pleural mesothelioma, caused by inhalation of asbestos fibres at work, at home or in the environment, is the most representative asbestos-related disease. The objectives of this study are to analyse the risk and protective factors associated with asbestos-related diseases and to investigate the incidence of new clinical manifestations in patients already diagnosed with some form of ARD. Methods/Design We have designed a matched case–control study with follow up of both cohorts from a population of a health district of the Barcelona province that has been exposed to asbestos for a period of 90 years. Discussion A better understanding of asbestos-related diseases should improve i) the clinical and epidemiological follow up of patients with this condition; ii) the design of new treatment strategies; iii) and the development of preventive activities. At the end of the study, the two cohorts created in this study (affected cases and healthy controls) will constitute the basis for future research. PMID:23915043

Design and Rationale of the Intima-Medial Thickness Sub-Study of the PreventIon of CArdiovascular Events in iSchemic Stroke Patients with High Risk of Cerebral hemOrrhage (PICASSO-IMT) Study.

PubMed

Seo, Woo-Keun; Kim, Yong Jae; Lee, Juneyoung; Kwon, Sun U

2017-09-01

Atherosclerosis is one of the main mechanisms of stroke and cardiovascular diseases and is associated with increased risk of recurrent stroke and cardiovascular events. Intima-medial thickness (IMT) is a well-known surrogate marker of atherosclerosis and has been used to predict stroke and cardiovascular events. However, the clinical significance of IMT and IMT change in stroke has not been investigated in well-designed studies. The PreventIon of CArdiovascular events in iSchemic Stroke patients with high risk of cerebral hemOrrhage-Intima-Media Thickness (PICASSO-IMT) sub-study is designed to investigate the effects of cilostazol, probucol, or both on IMT in patients with stroke. PICASSO-IMT is a prospective sub-study of the PICASSO study designed to measure IMT and plaque score at 1, 13, 25, 37, and 49 months after randomization. The primary outcome is the change in mean carotid IMT, which is defined as the mean of the far-wall IMTs of the right and left common carotid arteries, between baseline and 13 months after randomization. PICASSO-IMT will provide the largest IMT data set in a stroke population and will provide valuable information about the clinical significance of IMT in patients with ischemic stroke. Copyright © 2017 National Stroke Association. Published by Elsevier Inc. All rights reserved.

Aragon workers' health study - design and cohort description

USDA-ARS?s Scientific Manuscript database

Spain, a Mediterranean country with relatively low rates of coronary heart disease, has a high prevalence of traditional cardiovascular risk factors and is experiencing a severe epidemic of overweight/obesity. We designed the Aragon Workers' Health Study (AWHS) to characterize the factors associated...

Statins and Risk of Lower Limb Revision Surgery: The Influence of Differences in Study Design Using Electronic Health Records From the United Kingdom and Denmark

PubMed Central

Lalmohamed, Arief; van Staa, Tjeerd P.; Vestergaard, Peter; Leufkens, Hubertus G. M.; de Boer, Anthonius; Emans, Pieter; Cooper, Cyrus; de Vries, Frank

2016-01-01

Abstract Previous observational studies on statins have shown variable results based on the methodology used. Our objective was to study the association between statins and orthopedic implant failure and to explore the influence of methodological differences in study design. Our study base consisted of patients with a primary total joint replacement in Denmark and the United Kingdom (n = 189,286; 1987–2012). We used 4 study designs: 1) case-control (each patient with revision surgery matched to 4 controls), 2) time-dependent cohort (postoperative statin use as a time-varying exposure variable), 3) immortal time cohort (misclassifying the time postoperatively before statin use), and 4) time-exclusion cohort (excluding the time postoperatively before statin use). Cox proportional hazards models and logistic regression were used to estimate incidence rate ratios. In the time-dependent cohort design, statin use was associated with a decreased risk of revision surgery (adjusted incidence rate ratio (IRR) = 0.90, 95% confidence interval (CI): 0.85, 0.96), which was similar to our case-control results (IRR = 0.87, 95% CI: 0.81, 0.93). In contrast, both time-fixed cohort designs yielded substantially lower risk estimates (IRR = 0.36 (95% CI: 0.34, 0.38) and IRR = 0.65 (95% CI: 0.63, 0.68), respectively). We discourage the use of time-fixed cohort studies, which may falsely suggest protective effects. The simple choice of how to classify exposure can substantially change results from biologically plausible to implausible. PMID:27317693

Patient centered fall risk awareness perspectives: clinical correlates and fall risk

PubMed Central

Verghese, Joe

2016-01-01

Background While objective measures to assess risk of falls in older adults have been established; the value of patient self-reports in the context of falls is not known. Objectives To identify clinical correlates of patient centered fall risk awareness, and their validity for predicting falls. Design Prospective cohort study. Setting and Participants 316 non-demented and ambulatory community-dwelling older adults (mean age 78 years, 55% women). Measurements Fall risk awareness was assessed with a two-item questionnaire, which asked participants about overall likelihood and personal risk of falling over the next 12 months. Incident falls were recorded over study follow-up. Results Fifty-three participants (16.8%) responded positively to the first fall risk awareness question about being likely to have a fall in the next 12 months, and 100 (31.6%) reported being at personal risk of falling over the next 12 months. There was only fair correlation (kappa 0.370) between responses on the two questions. Prior falls and depressive symptoms were associated with positive responses on both fall risk awareness questions. Age and other established fall risk factors were not associated with responses on both fall risk awareness questions. The fall risk awareness questionnaire did not predict incident falls or injurious falls. Conclusion Fall risk awareness is low in older adults. While patient centered fall risk awareness is not predictive of falls, subjective risk perceptions should be considered when designing fall preventive strategies as they may influence participation and behaviors. PMID:27801936

Rationale and design for the Predictors of Arrhythmic and Cardiovascular Risk in End Stage Renal Disease (PACE) study.

PubMed

Parekh, Rulan S; Meoni, Lucy A; Jaar, Bernard G; Sozio, Stephen M; Shafi, Tariq; Tomaselli, Gordon F; Lima, Joao A; Tereshchenko, Larisa G; Estrella, Michelle M; Kao, W H Linda

2015-04-24

Sudden cardiac death occurs commonly in the end-stage renal disease population receiving dialysis, with 25% dying of sudden cardiac death over 5 years. Despite this high risk, surprisingly few prospective studies have studied clinical- and dialysis-related risk factors for sudden cardiac death and arrhythmic precursors of sudden cardiac death in end-stage renal disease. We present a brief summary of the risk factors for arrhythmias and sudden cardiac death in persons with end-stage renal disease as the rationale for the Predictors of Arrhythmic and Cardiovascular Risk in End Stage Renal Disease (PACE) study, a prospective cohort study of patients recently initiated on chronic hemodialysis, with the overall goal to understand arrhythmic and sudden cardiac death risk. Participants were screened for eligibility and excluded if they already had a pacemaker or an automatic implantable cardioverter defibrillator. We describe the study aims, design, and data collection of 574 incident hemodialysis participants from the Baltimore region in Maryland, U.S.A.. Participants were recruited from 27 hemodialysis units and underwent detailed clinical, dialysis and cardiovascular evaluation at baseline and follow-up. Cardiovascular phenotyping was conducted on nondialysis days with signal averaged electrocardiogram, echocardiogram, pulse wave velocity, ankle, brachial index, and cardiac computed tomography and angiography conducted at baseline. Participants were followed annually with study visits including electrocardiogram, pulse wave velocity, and ankle brachial index up to 4 years. A biorepository of serum, plasma, DNA, RNA, and nails were collected to study genetic and serologic factors associated with disease. Studies of modifiable risk factors for sudden cardiac death will help set the stage for clinical trials to test therapies to prevent sudden cardiac death in this high-risk population.

Personal use of hair dyes and the risk of bladder cancer: results of a meta-analysis.

PubMed Central

Huncharek, Michael; Kupelnick, Bruce

2005-01-01

OBJECTIVE: This study examined the methodology of observational studies that explored an association between personal use of hair dye products and the risk of bladder cancer. METHODS: Data were pooled from epidemiological studies using a general variance-based meta-analytic method that employed confidence intervals. The outcome of interest was a summary relative risk (RRs) reflecting the risk of bladder cancer development associated with use of hair dye products vs. non-use. Sensitivity analyses were performed to explain any observed statistical heterogeneity and to explore the influence of specific study characteristics of the summary estimate of effect. RESULTS: Initially combining homogenous data from six case-control and one cohort study yielded a non-significant RR of 1.01 (0.92, 1.11), suggesting no association between hair dye use and bladder cancer development. Sensitivity analyses examining the influence of hair dye type, color, and study design on this suspected association showed that uncontrolled confounding and design limitations contributed to a spurious non-significant summary RR. The sensitivity analyses yielded statistically significant RRs ranging from 1.22 (1.11, 1.51) to 1.50 (1.30, 1.98), indicating that personal use of hair dye products increases bladder cancer risk by 22% to 50% vs. non-use. CONCLUSION: The available epidemiological data suggest an association between personal use of hair dye products and increased risk of bladder cancer. PMID:15736329

Flavonoids, Flavonoid Subclasses, and Esophageal Cancer Risk: A Meta-Analysis of Epidemiologic Studies

PubMed Central

Cui, Lingling; Liu, Xinxin; Tian, Yalan; Xie, Chen; Li, Qianwen; Cui, Han; Sun, Changqing

2016-01-01

Flavonoids have been suggested to play a chemopreventive role in carcinogenesis. However, the epidemiologic studies assessing dietary intake of flavonoids and esophageal cancer risk have yielded inconsistent results. This study was designed to examine the association between flavonoids, each flavonoid subclass, and the risk of esophageal cancer with a meta-analysis approach. We searched for all relevant studies with a prospective cohort or case-control study design published from January 1990 to April 2016, using PUBMED, EMBASE, and Web of Science. Pooled odds ratios (ORs) were calculated using fixed or random-effect models. In total, seven articles including 2629 cases and 481,193 non-cases were selected for the meta-analysis. Comparing the highest-intake patients with the lowest-intake patients for total flavonoids and for each flavonoid subclass, we found that anthocyanidins (OR = 0.60, 95% CI: 0.49–0.74), flavanones (OR = 0.65, 95% CI: 0.49–0.86), and flavones (OR = 0.78, 95% CI 0.64–0.95) were inversely associated with the risk of esophageal cancer. However, total flavonoids showed marginal association with esophageal cancer risk (OR = 0.78, 95% CI: 0.59–1.04). In conclusion, our study suggested that dietary intake of total flavonoids, anthocyanidins, flavanones, and flavones might reduce the risk of esophageal cancer. PMID:27338463

Coronary Heart Disease Knowledge and Risk Factors among Tri-Ethnic College Students

ERIC Educational Resources Information Center

Koutoubi, Samer; Huffman, Fatma G.; Ciccazzo, Michele W.; Himburg, Susan P.; Johnson, Paulette

2005-01-01

Objectives: Coronary heart disease (CHD) is the leading cause of death in the United States and Europe. This study identified and compared nutritional knowledge associated with CHD risk factors among tri-ethnic college students. Design: A quantitative, cross-sectional, observational study using questionnaires. Setting: University laboratory.…

An Effective Approach to Violence Prevention: Traditional Martial Arts in Middle School.

ERIC Educational Resources Information Center

Zivin, Gail; Hassan, Nimr R.; DePaula, Geraldine F.; Monti, Daniel A.; Harlan, Carmen; Hossain, Kashfia D.; Patterson, Ksai

2001-01-01

Replicated and extended the design and outcome measures of several small studies. In these studies, juveniles at high risk for violence and delinquency showed decreased violence and positive changes in psychological risk factors after being required to take a school-linked course in traditional martial arts. (Author)

LinkIT: a ludic elicitation game for eliciting risk perceptions.

PubMed

Cao, Yan; McGill, William L

2013-06-01

The mental models approach, a leading strategy to develop risk communications, involves a time- and labor-intensive interview process and a lengthy questionnaire to elicit group-level risk perceptions. We propose that a similarity ratings approach for structural knowledge elicitation can be adopted to assist the risk mental models approach. The LinkIT game, inspired by games with a purpose (GWAP) technology, is a ludic elicitation tool designed to elicit group understanding of the relations between risk factors in a more enjoyable and productive manner when compared to traditional approaches. That is, consistent with the idea of ludic elicitation, LinkIT was designed to make the elicitation process fun and enjoyable in the hopes of increasing participation and data quality in risk studies. Like the mental models approach, the group mental model obtained via the LinkIT game can hence be generated and represented in a form of influence diagrams. In order to examine the external validity of LinkIT, we conducted a study to compare its performance with respect to a more conventional questionnaire-driven approach. Data analysis results conclude that the two group mental models elicited from the two approaches are similar to an extent. Yet, LinkIT was more productive and enjoyable than the questionnaire. However, participants commented that the current game has some usability concerns. This presentation summarizes the design and evaluation of the LinkIT game and suggests areas for future work. © 2012 Society for Risk Analysis.

Screening for increased cardiometabolic risk in primary care: a systematic review

PubMed Central

den Engelsen, Corine; Koekkoek, Paula S; Godefrooij, Merijn B; Spigt, Mark G; Rutten, Guy E

2014-01-01

Background Many programmes to detect and prevent cardiovascular disease (CVD) have been performed, but the optimal strategy is not yet clear. Aim To present a systematic review of cardiometabolic screening programmes performed among apparently healthy people (not yet known to have CVD, diabetes, or cardiometabolic risk factors) and mixed populations (apparently healthy people and people diagnosed with risk factor or disease) to define the optimal screening strategy. Design and setting Systematic review of studies performed in primary care in Western countries. Method MEDLINE, Embase, and CINAHL databases were searched for studies screening for increased cardiometabolic risk. Exclusion criteria were studies designed to assess prevalence of risk factors without follow-up or treatment; without involving a GP; when fewer than two risk factors were considered as the primary outcome; and studies constrained to ethnic minorities. Results The search strategy yielded 11 445 hits; 26 met the inclusion criteria. Five studies (1995–2012) were conducted in apparently healthy populations: three used a stepwise method. Response rates varied from 24% to 79%. Twenty-one studies (1967–2012) were performed in mixed populations; one used a stepwise method. Response rates varied from 50% to 75%. Prevalence rates could not be compared because of heterogeneity of used thresholds and eligible populations. Observed time trends were a shift from mixed to apparently healthy populations, increasing use of risk scores, and increasing use of stepwise screening methods. Conclusion The optimal screening strategy in primary care is likely stepwise, in apparently healthy people, with the use of risk scores. Increasing public awareness and actively involving GPs might facilitate screening efficiency and uptake. PMID:25267047

Childhood brain tumour risk and its association with wireless phones: a commentary

PubMed Central

2011-01-01

Case-control studies on adults point to an increased risk of brain tumours (glioma and acoustic neuroma) associated with the long-term use of mobile phones. Recently, the first study on mobile phone use and the risk of brain tumours in children and adolescents, CEFALO, was published. It has been claimed that this relatively small study yielded reassuring results of no increased risk. We do not agree. We consider that the data contain several indications of increased risk, despite low exposure, short latency period, and limitations in the study design, analyses and interpretation. The information certainly cannot be used as reassuring evidence against an association, for reasons that we discuss in this commentary. PMID:22182218

Childhood brain tumour risk and its association with wireless phones: a commentary.

PubMed

Söderqvist, Fredrik; Carlberg, Michael; Hansson Mild, Kjell; Hardell, Lennart

2011-12-19

Case-control studies on adults point to an increased risk of brain tumours (glioma and acoustic neuroma) associated with the long-term use of mobile phones. Recently, the first study on mobile phone use and the risk of brain tumours in children and adolescents, CEFALO, was published. It has been claimed that this relatively small study yielded reassuring results of no increased risk. We do not agree. We consider that the data contain several indications of increased risk, despite low exposure, short latency period, and limitations in the study design, analyses and interpretation. The information certainly cannot be used as reassuring evidence against an association, for reasons that we discuss in this commentary.

Glutathione-S-transferase polymorphisms (GSTM1, GSTT1 and GSTP1) and acute leukemia risk in Asians: a meta-analysis.

PubMed

Tang, Zhen-Hai; Zhang, Chi; Cheng, Pan; Sun, Hong-Min; Jin, Yu; Chen, Yuan-Jing; Huang, Fen

2014-01-01

The association between glutathione-S-transferase polymorphisms (GSTM1, GSTT1 and GSTP1) and risk of acute leukemia in Asians remains controversial. This study was therefore designed to evaluate the precise association in 23 studies identified by a search of PubMed and several other databases, up to December 2013. Using random or fixed effects models odds ratios (ORs) with corresponding 95% confidence intervals (CIs) were calculated. Heterogeneity across studies was assessed, and funnel plots were constructed to test for publication bias. The meta-analysis showed positive associations between GST polymorphisms (GSTM1 and GSTT1 but not GSTP1) and acute leukemia risk [(OR=1.47, 95% CI 1.18-1.83); (OR=1.32, 95% CI 1.07-1.62); (OR=1.01, 95% CI 0.84-1.23), respectively] and heterogeneity between the studies. The results suggested that the GSTM1 null genotype and GSTT1null genotype, but not the GSTP1 polymorphism, might be a potential risk factors for acute leukemia. Further well-designed studies are needed to confirm our findings.

Impact of a Career Intervention on At-Risk Middle School Students' Career Maturity Levels, Academic Achievement, and Self-Esteem

ERIC Educational Resources Information Center

Legum, Harry L.; Hoare, Carol H.

2004-01-01

The purpose of this study was to assess the effects of a 9-week career intervention program on at-risk middle school students' career maturity levels, self-esteem, and academic achievement. This study was based on a pretest and posttest design using a control group. Data were collected from 27 at-risk middle school students representing the…

Caries Risk Assessment Item Importance

PubMed Central

Chaffee, B.W.; Featherstone, J.D.B.; Gansky, S.A.; Cheng, J.; Zhan, L.

2016-01-01

Caries risk assessment (CRA) is widely recommended for dental caries management. Little is known regarding how practitioners use individual CRA items to determine risk and which individual items independently predict clinical outcomes in children younger than 6 y. The objective of this study was to assess the relative importance of pediatric CRA items in dental providers’ decision making regarding patient risk and in association with clinically evident caries, cross-sectionally and longitudinally. CRA information was abstracted retrospectively from electronic patient records of children initially aged 6 to 72 mo at a university pediatric dentistry clinic (n = 3,810 baseline; n = 1,315 with follow-up). The 17-item CRA form included caries risk indicators, caries protective items, and clinical indicators. Conditional random forests classification trees were implemented to identify and assign variable importance to CRA items independently associated with baseline high-risk designation, baseline evident tooth decay, and follow-up evident decay. Thirteen individual CRA items, including all clinical indicators and all but 1 risk indicator, were independently and statistically significantly associated with student/resident providers’ caries risk designation. Provider-assigned baseline risk category was strongly associated with follow-up decay, which increased from low (20.4%) to moderate (30.6%) to high/extreme risk patients (68.7%). Of baseline CRA items, before adjustment, 12 were associated with baseline decay and 7 with decay at follow-up; however, in the conditional random forests models, only the clinical indicators (evident decay, dental plaque, and recent restoration placement) and 1 risk indicator (frequent snacking) were independently and statistically significantly associated with future disease, for which baseline evident decay was the strongest predictor. In this predominantly high-risk population under caries-preventive care, more individual CRA items were independently associated with providers’ risk determination than with future caries status. These university dental providers considered many items in decision making regarding patient risk, suggesting that, in turn, these comprehensive CRA forms could also aid individualized care, linking risk assessment to disease management. Knowledge Transfer Statement: Caries risk assessment (CRA) is widely recommended for patient-tailored, prevention-focused caries management. Studies show mixed predictive performance of pediatric CRA instruments, but little is known regarding how information captured in CRA forms guides clinical decision making. This study, in high-caries prevalence 6- to 72-mo-olds, demonstrates the following: 1) most items in a CRA instrument were independently associated with practitioners’ risk designations, 2) practitioners’ risk designations were significantly associated with future disease, and 3) of baseline measures associated with future caries, evident decay was the strongest independent indicator of future caries status. Although current disease (resulting from existing pathological and protective factor imbalance) may sufficiently predict future caries status in populations, other CRA items incorporated during risk categorization could aid practitioners to develop individualized intervention strategies against identified risk factors. PMID:27403458

Environmental risk factors for autism: an evidence-based review of systematic reviews and meta-analyses.

PubMed

Modabbernia, Amirhossein; Velthorst, Eva; Reichenberg, Abraham

2017-01-01

According to recent evidence, up to 40-50% of variance in autism spectrum disorder (ASD) liability might be determined by environmental factors. In the present paper, we conducted a review of systematic reviews and meta-analyses of environmental risk factors for ASD. We assessed each review for quality of evidence and provided a brief overview of putative mechanisms of environmental risk factors for ASD. Current evidence suggests that several environmental factors including vaccination, maternal smoking, thimerosal exposure, and most likely assisted reproductive technologies are unrelated to risk of ASD. On the contrary, advanced parental age is associated with higher risk of ASD. Birth complications that are associated with trauma or ischemia and hypoxia have also shown strong links to ASD, whereas other pregnancy-related factors such as maternal obesity, maternal diabetes, and caesarian section have shown a less strong (but significant) association with risk of ASD. The reviews on nutritional elements have been inconclusive about the detrimental effects of deficiency in folic acid and omega 3, but vitamin D seems to be deficient in patients with ASD. The studies on toxic elements have been largely limited by their design, but there is enough evidence for the association between some heavy metals (most important inorganic mercury and lead) and ASD that warrants further investigation. Mechanisms of the association between environmental factors and ASD are debated but might include non-causative association (including confounding), gene-related effect, oxidative stress, inflammation, hypoxia/ischemia, endocrine disruption, neurotransmitter alterations, and interference with signaling pathways. Compared to genetic studies of ASD, studies of environmental risk factors are in their infancy and have significant methodological limitations. Future studies of ASD risk factors would benefit from a developmental psychopathology approach, prospective design, precise exposure measurement, reliable timing of exposure in relation to critical developmental periods and should take into account the dynamic interplay between gene and environment by using genetically informed designs.

Activation of the prefrontal cortex by unilateral transcranial direct current stimulation leads to an asymmetrical effect on risk preference in frames of gain and loss.

PubMed

Ye, Hang; Huang, Daqiang; Wang, Siqi; Zheng, Haoli; Luo, Jun; Chen, Shu

2016-10-01

Previous brain imaging and brain stimulation studies have suggested that the dorsolateral prefrontal cortex may be critical in regulating risk-taking behavior, although its specific causal effect on people's risk preference remains controversial. This paper studied the independent modulation of the activity of the right and left dorsolateral prefrontal cortex using various configurations of transcranial direct current stimulation. We designed a risk-measurement table and adopted a within-subject design to compare the same participant's risk preference before and after unilateral stimulation when presented with different frames of gain and loss. The results confirmed a hemispheric asymmetry and indicated that the right dorsolateral prefrontal cortex has an asymmetric effect on risk preference regarding frames of gain and loss. Enhancing the activity of the right dorsolateral prefrontal cortex significantly decreased the participants' degree of risk aversion in the gain frame, whereas it increased the participants' degree of risk aversion in the loss frame. Our findings provide important information regarding the impact of transcranial direct current stimulation on the risk preference of healthy participants. The effects observed in our experiment compared with those of previous studies provide further evidence of the effects of hemispheric and frame-dependent asymmetry. These findings may be helpful in understanding the neural basis of risk preference in humans, especially when faced with decisions involving possible gain or loss relative to the status quo. Copyright © 2016 Elsevier B.V. All rights reserved.

Using electronic health record data for substance use Screening, Brief Intervention, and Referral to Treatment among adults with type 2 diabetes: Design of a National Drug Abuse Treatment Clinical Trials Network study.

PubMed

Wu, Li-Tzy; Brady, Kathleen T; Spratt, Susan E; Dunham, Ashley A; Heidenfelder, Brooke; Batch, Bryan C; Lindblad, Robert; VanVeldhuisen, Paul; Rusincovitch, Shelley A; Killeen, Therese K; Ghitza, Udi E

2016-01-01

The Affordable Care Act encourages healthcare systems to integrate behavioral and medical healthcare, as well as to employ electronic health records (EHRs) for health information exchange and quality improvement. Pragmatic research paradigms that employ EHRs in research are needed to produce clinical evidence in real-world medical settings for informing learning healthcare systems. Adults with comorbid diabetes and substance use disorders (SUDs) tend to use costly inpatient treatments; however, there is a lack of empirical data on implementing behavioral healthcare to reduce health risk in adults with high-risk diabetes. Given the complexity of high-risk patients' medical problems and the cost of conducting randomized trials, a feasibility project is warranted to guide practical study designs. We describe the study design, which explores the feasibility of implementing substance use Screening, Brief Intervention, and Referral to Treatment (SBIRT) among adults with high-risk type 2 diabetes mellitus (T2DM) within a home-based primary care setting. Our study includes the development of an integrated EHR datamart to identify eligible patients and collect diabetes healthcare data, and the use of a geographic health information system to understand the social context in patients' communities. Analysis will examine recruitment, proportion of patients receiving brief intervention and/or referrals, substance use, SUD treatment use, diabetes outcomes, and retention. By capitalizing on an existing T2DM project that uses home-based primary care, our study results will provide timely clinical information to inform the designs and implementation of future SBIRT studies among adults with multiple medical conditions. Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.

A Cross-Sectional Study on Attitudes to and Understanding of Risk of Acquisition of HIV: Design, Methods and Participant Characteristics

PubMed Central

Speakman, Andrew; Phillips, Andrew N; Lampe, Fiona C; Miltz, Ada; Gilson, Richard; Asboe, David; Nwokolo, Nneka; Scott, Christopher; Day, Sara; Clarke, Amanda; Anderson, Jane; O'Connell, Rebecca; Apea, Vanessa; Dhairyawan, Rageshri; Gompels, Mark; Farazmand, Paymaneh; Allan, Sris; Mann, Susan; Dhar, Jyoti; Tang, Alan; Sadiq, S Tariq; Taylor, Stephen; Collins, Simon; Sherr, Lorraine; Hart, Graham; Johnson, Anne M; Miners, Alec; Elford, Jonathan; Rodger, Alison

2016-01-01

Background The annual number of new human immunodeficiency virus (HIV) infections in the United Kingdom among men who have sex with men (MSM) has risen, and remains high among heterosexuals. Increasing HIV transmission among MSM is consistent with evidence of ongoing sexual risk behavior in this group, and targeted prevention strategies are needed for those at risk of acquiring HIV. Objective The Attitudes to and Understanding of Risk of Acquisition of HIV (AURAH) study was designed to collect information on HIV negative adults at risk of HIV infection in the United Kingdom, based on the following parameters: physical and mental health, lifestyle, patterns of sexual behaviour, and attitudes to sexual risk. Methods Cross-sectional questionnaire study of HIV negative or undiagnosed sexual health clinic attendees in the United Kingdom from 2013-2014. Results Of 2630 participants in the AURAH study, 2064 (78%) were in the key subgroups of interest; 580 were black Africans (325 females and 255 males) and 1484 were MSM, with 27 participants belonging to both categories. Conclusions The results from AURAH will be a significant resource to understand the attitudes and sexual behaviour of those at risk of acquiring HIV within the United Kingdom. AURAH will inform future prevention efforts and targeted health promotion initiatives in the HIV negative population. PMID:27091769

Meta-analysis on shift work and risks of specific obesity types.

PubMed

Sun, M; Feng, W; Wang, F; Li, P; Li, Z; Li, M; Tse, G; Vlaanderen, J; Vermeulen, R; Tse, L A

2018-01-01

This systematic review and meta-analysis evaluated the associations between shift work patterns and risks of specific types of obesity. PubMed was searched until March 2017 for observational studies that examined the relationships between shift work patterns and obesity. Odds ratio for obesity was extracted using a fixed-effects or random-effects model. Subgroup meta-analyses were carried out for study design, specific obesity types and characteristics of shift work pattern. A total of 28 studies were included in this meta-analysis. The overall odds ratio of night shift work was 1.23 (95% confidence interval = 1.17-1.29) for risk of obesity/overweight. Cross-sectional studies showed a higher risk of 1.26 than those with the cohort design (risk ratio = 1.10). Shift workers had a higher frequency of developing abdominal obesity (odds ratio = 1.35) than other obesity types. Permanent night workers demonstrated a 29% higher risk than rotating shift workers (odds ratio 1.43 vs. 1.14). This meta-analysis confirmed the risks of night shift work for the development of overweight and obesity with a potential gradient association suggested, especially for abdominal obesity. Modification of working schedules is recommended, particularly for prolonged permanent night work. More accurate and detailed measurements on shift work patterns should be conducted in future research. © 2017 World Obesity Federation.

Can lifestyle modification improve neurocognition? Rationale and design of the ENLIGHTEN clinical trial.

PubMed

Blumenthal, James A; Smith, Patrick J; Welsh-Bohmer, Kathleen; Babyak, Michael A; Browndyke, Jeffrey; Lin, Pao-Hwa; Doraiswamy, P Murali; Burke, James; Kraus, William; Hinderliter, Alan; Sherwood, Andrew

2013-01-01

Risk factors for cardiovascular disease (CVD) not only increase the risk for clinical CVD events, but also are associated with a cascade of neurophysiologic and neuroanatomic changes that increase the risk of cognitive impairment and dementia. Although epidemiological studies have shown that exercise and diet are associated with lower CVD risk and reduced incidence of dementia, no randomized controlled trial (RCT) has examined the independent effects of exercise and diet on neurocognitive function among individuals at risk for dementia. The ENLIGHTEN trial is a RCT of patients with CVD risk factors who also are characterized by subjective cognitive complaints and objective evidence of neurocognitive impairment without dementia (CIND) STUDY DESIGN: A 2 by 2 design will examine the independent and combined effects of diet and exercise on neurocognition. 160 participants diagnosed with CIND will be randomly assigned to 6 months of aerobic exercise, the DASH diet, or a combination of both exercise and diet; a (control) group will receive health education but otherwise will maintain their usual dietary and activity habits. Participants will complete comprehensive assessments of neurocognitive functioning along with biomarkers of CVD risk including measures of blood pressure, glucose, endothelial function, and arterial stiffness. The ENLIGHTEN trial will (a) evaluate the effectiveness of aerobic exercise and the DASH diet in improving neurocognitive functioning in CIND patients with CVD risk factors; (b) examine possible mechanisms by which exercise and diet improve neurocognition; and (c) consider potential moderators of treatment, including subclinical CVD. Copyright © 2012 Elsevier Inc. All rights reserved.

Developing a quality by design approach to model tablet dissolution testing: an industrial case study.

PubMed

Yekpe, Ketsia; Abatzoglou, Nicolas; Bataille, Bernard; Gosselin, Ryan; Sharkawi, Tahmer; Simard, Jean-Sébastien; Cournoyer, Antoine

2018-07-01

This study applied the concept of Quality by Design (QbD) to tablet dissolution. Its goal was to propose a quality control strategy to model dissolution testing of solid oral dose products according to International Conference on Harmonization guidelines. The methodology involved the following three steps: (1) a risk analysis to identify the material- and process-related parameters impacting the critical quality attributes of dissolution testing, (2) an experimental design to evaluate the influence of design factors (attributes and parameters selected by risk analysis) on dissolution testing, and (3) an investigation of the relationship between design factors and dissolution profiles. Results show that (a) in the case studied, the two parameters impacting dissolution kinetics are active pharmaceutical ingredient particle size distributions and tablet hardness and (b) these two parameters could be monitored with PAT tools to predict dissolution profiles. Moreover, based on the results obtained, modeling dissolution is possible. The practicality and effectiveness of the QbD approach were demonstrated through this industrial case study. Implementing such an approach systematically in industrial pharmaceutical production would reduce the need for tablet dissolution testing.

A randomized controlled exercise training trial on insulin sensitivity in African American men: The ARTIIS study: Major category: study design, statistical design, study protocols.

PubMed

Newton, Robert L; Johnson, William D; Hendrick, Chelsea; Harris, Melissa; Andrews, Emanuel; Johannsen, Neil; Rodarte, Ruben Q; Hsia, Daniel S; Church, Timothy S

2015-07-01

Lack of regular physical activity at prescribed intensity levels is a modifiable risk factor for insulin resistance and the development of diabetes. African American men are at increased risk for developing diabetes and most African American men are not meeting the current recommended levels of physical activity. The primary objective of the Aerobic Plus Resistance Training and Insulin Resistance in African American Men (ARTIIS) study is to determine the effectiveness of an exercise training intervention aimed at reducing diabetes risk factors in African American men at risk for developing diabetes. Insufficiently active 35-70 year old African American men with a family history of diabetes were eligible for the study. The 5-month randomized controlled trial assigns 116 men to an exercise training or healthy living control arm. The exercise training arm combines aerobic and resistance training according to the current national physical activity recommendations and is conducted in community (YMCA) facilities. The healthy living arm receives information promoting healthy lifestyle changes. Insulin response to an oral glucose load is the primary outcome measure, and changes in physiological parameters, cardiorespiratory fitness, strength, body composition, and psychological well-being comprise the secondary outcomes. The ARTIIS study is one of the first adequately powered, rigorously designed studies to investigate the effects of an aerobic plus resistance exercise training program and to assess adherence to exercise training in community facilities, in African American men. Copyright © 2015 Elsevier Inc. All rights reserved.

Researcher Risk Perception in Educational Research

ERIC Educational Resources Information Center

Wells, Cris

2010-01-01

Throughout history human subject research has been plagued by researchers whose studies were riddled with danger and/or risk to their subjects. Indeed, one may cite numerous situations where human subjects were injured and/or killed in experiments that were designed with no thought or anticipation of risk to the subjects. As a result, the federal…

Clinical prediction of fall risk and white matter abnormalities: a diffusion tensor imaging study

USDA-ARS?s Scientific Manuscript database

The Tinetti scale is a simple clinical tool designed to predict risk of falling by focusing on gait and stance impairment in elderly persons. Gait impairment is also associated with white matter (WM) abnormalities. Objective: To test the hypothesis that elderly subjects at risk for falling, as deter...

The Nightingale study: rationale, study design and baseline characteristics of a prospective cohort study on shift work and breast cancer risk among nurses

PubMed Central

2014-01-01

Background Evidence for the carcinogenicity of shift work in humans is limited because of significant heterogeneity of the results, thus more in-depth research in needed. The Nightingale Study is a nationwide prospective cohort study on occupational exposures and risks of chronic diseases among female nurses and focuses on the potential association between shift work and risk of breast cancer. The study design, methods, and baseline characteristics of the cohort are described. Methods/Design The source population for the cohort comprised 18 to 65 year old women who were registered as having completed training to be a nurse in the nationwide register for healthcare professionals in the Netherlands. Eligible women were invited to complete a web-based questionnaire including full job history, a detailed section on all domains of shift work (shift system, cumulative exposure, and shift intensity) and potential confounding factors, and an informed consent form for linkage with national (disease) registries. Women were also asked to donate toenail clippings as a source of DNA for genetic analyses. Between October 6, 2011 and February 1, 2012, 31% of the 192,931 women who were invited to participate completed the questionnaire, yielding a sample size of 59,947 cohort members. The mean age of the participants was 46.9 year (standard deviation 11.0 years). Toenail clippings were provided by 23,439 participants (39%). Discussion Results from the Nightingale Study will contribute to the scientific evidence of potential shift work-related health risks among nurses and will help develop preventive measures and policy aimed at reducing these risks. PMID:24475944

Stakeholder Perceptions of Risk in Construction.

PubMed

Zhao, Dong; McCoy, Andrew P; Kleiner, Brian M; Mills, Thomas H; Lingard, Helen

2016-02-01

Safety management in construction is an integral effort and its success requires inputs from all stakeholders across design and construction phases. Effective risk mitigation relies on the concordance of all stakeholders' risk perceptions. Many researchers have noticed the discordance of risk perceptions among critical stakeholders in safe construction work, however few have provided quantifiable evidence describing them. In an effort to fill this perception gap, this research performs an experiment that investigates stakeholder perceptions of risk in construction. Data analysis confirms the existence of such discordance, and indicates a trend in risk likelihood estimation. With risk perceptions from low to high, the stakeholders are architects, contractors/safety professionals, and engineers. Including prior studies, results also suggest that designers have improved their knowledge in building construction safety, but compared to builders they present more difficultly in reaching a consensus of perception. Findings of this research are intended to be used by risk management and decision makers to reassess stakeholders' varying judgments when considering injury prevention and hazard assessment.

Stakeholder Perceptions of Risk in Construction

PubMed Central

Zhao, Dong; McCoy, Andrew P.; Kleiner, Brian M.; Mills, Thomas H.; Lingard, Helen

2015-01-01

Safety management in construction is an integral effort and its success requires inputs from all stakeholders across design and construction phases. Effective risk mitigation relies on the concordance of all stakeholders’ risk perceptions. Many researchers have noticed the discordance of risk perceptions among critical stakeholders in safe construction work, however few have provided quantifiable evidence describing them. In an effort to fill this perception gap, this research performs an experiment that investigates stakeholder perceptions of risk in construction. Data analysis confirms the existence of such discordance, and indicates a trend in risk likelihood estimation. With risk perceptions from low to high, the stakeholders are architects, contractors/safety professionals, and engineers. Including prior studies, results also suggest that designers have improved their knowledge in building construction safety, but compared to builders they present more difficultly in reaching a consensus of perception. Findings of this research are intended to be used by risk management and decision makers to reassess stakeholders’ varying judgments when considering injury prevention and hazard assessment. PMID:26441481

DESIGN OF FIELD STUDIES FOR THE MEASUREMENT OF BAFS AND BSAFS.

EPA Science Inventory

Bioaccumulation factors (BAFs) and biota-sediment accumulation factors (BSAFs) for aquatic organisms are necessary parameters for assessing the ecological risks of nonpolar organic chemicals in aquatic ecosystems. In designing a field study to measure BAFs and/or BSAFs, one of th...

Comprehensive risk analysis for structure type selection.

DOT National Transportation Integrated Search

2010-04-01

Optimization of bridge selection and design traditionally has been sought in terms of the finished structure. This study presents a : more comprehensive risk-based analysis that includes user costs and accidents during the construction phase. Costs f...

Review of Single Subject Research Examining the Effectiveness of Interventions for At-Risk English Learners

ERIC Educational Resources Information Center

Baker, Doris Luft; Richards-Tutor, Catherine; Sparks, Anthony; Canges, Rebecca

2018-01-01

We review published single subject design (SSD) studies that examine the effects of interventions for English learners at-risk or with learning disabilities. Results of our literature search yielded 10 studies, five in reading, one in reading and behavior, and four in mathematics that met our inclusion criteria. Seven studies targeted…

Cancer risks from exposure to radon in homes.

PubMed

Axelson, O

1995-03-01

Exposure to radon and its decay products in mines is a well recognized risk of lung cancer in miners. A large number of epidemiologic studies from various countries are quite consistent in this respect even it the magnitude of the risk differs according to exposure levels. Indoor radon became a concern in the 1970s and about a dozen studies have been conducted since 1979, mainly of the case-control design. From first being of a simple pilot character, the designs have become increasingly sophisticated, especially with regard to exposure assessment. Crude exposure estimates based on type of house, building material and geological features have been supplemented or replaced by quite extensive measurements. Still, exposure assessment remains a difficult and uncertain issue in these studies, most of which indicate a lung cancer risk from indoor radon. Also a recent large scale study has confirmed a lung cancer risk from indoor radon. More recently there are also some studies, mainly of the correlation type, suggesting other cancers also to be related to indoor radon, especially leukemia, kidney cancer, and malignant melanoma, and some other cancers as well. The data are less consistent and much more uncertain than for indoor radon and lung cancer, however; and there is no clear support from studies of miners in this respect.

Cancer Risks near Nuclear Facilities: The Importance of Research Design and Explicit Study Hypotheses

PubMed Central

Wing, Steve; Richardson, David B.; Hoffmann, Wolfgang

2011-01-01

Background In April 2010, the U.S. Nuclear Regulatory Commission asked the National Academy of Sciences to update a 1990 study of cancer risks near nuclear facilities. Prior research on this topic has suffered from problems in hypothesis formulation and research design. Objectives We review epidemiologic principles used in studies of generic exposure–response associations and in studies of specific sources of exposure. We then describe logical problems with assumptions, formation of testable hypotheses, and interpretation of evidence in previous research on cancer risks near nuclear facilities. Discussion Advancement of knowledge about cancer risks near nuclear facilities depends on testing specific hypotheses grounded in physical and biological mechanisms of exposure and susceptibility while considering sample size and ability to adequately quantify exposure, ascertain cancer cases, and evaluate plausible confounders. Conclusions Next steps in advancing knowledge about cancer risks near nuclear facilities require studies of childhood cancer incidence, focus on in utero and early childhood exposures, use of specific geographic information, and consideration of pathways for transport and uptake of radionuclides. Studies of cancer mortality among adults, cancers with long latencies, large geographic zones, and populations that reside at large distances from nuclear facilities are better suited for public relations than for scientific purposes. PMID:21147606

Cancer risks from exposure to radon in homes.

PubMed Central

Axelson, O

1995-01-01

Exposure to radon and its decay products in mines is a well recognized risk of lung cancer in miners. A large number of epidemiologic studies from various countries are quite consistent in this respect even it the magnitude of the risk differs according to exposure levels. Indoor radon became a concern in the 1970s and about a dozen studies have been conducted since 1979, mainly of the case-control design. From first being of a simple pilot character, the designs have become increasingly sophisticated, especially with regard to exposure assessment. Crude exposure estimates based on type of house, building material and geological features have been supplemented or replaced by quite extensive measurements. Still, exposure assessment remains a difficult and uncertain issue in these studies, most of which indicate a lung cancer risk from indoor radon. Also a recent large scale study has confirmed a lung cancer risk from indoor radon. More recently there are also some studies, mainly of the correlation type, suggesting other cancers also to be related to indoor radon, especially leukemia, kidney cancer, and malignant melanoma, and some other cancers as well. The data are less consistent and much more uncertain than for indoor radon and lung cancer, however; and there is no clear support from studies of miners in this respect. PMID:7614945

Submersible Aircraft Concept Design Study - Amendment 1. Additional Assessment of Design Risks & Sensitivities within the Original Study, and an Initial Assessment of Key Control Aspects

DTIC Science & Technology

2011-02-01

http://www.redhammer.se/tornado/index.html (3) Aircraft Design: A Conceptual Approach, Daniel P. Raymer , AIAA, 1992 (4) (5) Moran, J., Computational...Fluid Dynamics, Wiley & Sons, 1984. Notes on the Stability and Control of Tailless Airplanes, Robert T. Jones, NACA Technical Note No.837, December

Estimating the Occurrence of Child Maltreatment and Risk-Factor Effects: Benefits of a Mixed-Design Strategy in Epidemiologic Research.

ERIC Educational Resources Information Center

Bertolli, Jeanne; And Others

1995-01-01

This article discusses methodologic limitations of four observational study designs (ecologic, case-control, cross-sectional, and cohort) that dominate the child abuse and neglect literature and identifies key features of an "ideal" study of child maltreatment. It proposes a new mixed-design strategy, which improves ability to identify child…

Environmental- and health-risk-induced remediation design for benzene-contaminated groundwater under parameter uncertainty: a case study in Western Canada.

PubMed

Fan, X; He, L; Lu, H W; Li, J

2014-09-01

This study proposes an environmental- and health-risk-induced remediation design approach for benzene-contaminated groundwater. It involves exposure frequency and intake rates that are important but difficult to be exactly quantified as breakthrough point. Flexible health-risk control is considered in the simulation and optimization work. The proposed approach is then applied to a petroleum-contaminated site in western Canada. Different situations about remediation durations, public concerns, and satisfactory degrees are addressed by the approach. The relationship between environmental standards and health-risk limits is analyzed, in association with their effect on remediation costs. Insights of three uncertain factors (i.e. exposure frequency, intake rate and health-risk threshold) for the remediation system are also explored, on a basis of understanding their impacts on health risk as well as their importance order. The case study results show that (1) nature attenuation plays a more important role in long-term remediation scheme than the pump-and-treat system; (2) carcinogenic risks have greater impact on total pumping rates than environmental standards for long-term remediation; (3) intake rates are the second important factor affecting the remediation system's performance, followed by exposure frequency; (4) the 10-year remediation scheme is the most robust choice when environmental and health-risk concerns are not well quantified. Copyright © 2014 Elsevier Ltd. All rights reserved.

X-37 Storable Propulsion System Design and Operations

NASA Technical Reports Server (NTRS)

Rodriguez, Henry; Popp, Chris; Rehagen, Ronald J.

2005-01-01

In a response to NASA's X-37 TA-10 Cycle-1 contract, Boeing assessed nitrogen tetroxide (N2O4) and monomethyl hydrazine (MMH) Storable Propellant Propulsion Systems to select a low risk X-37 propulsion development approach. Space Shuttle lessons learned, planetary spacecraft, and Boeing Satellite HS-601 systems were reviewed to arrive at a low risk and reliable storable propulsion system. This paper describes the requirements, trade studies, design solutions, flight and ground operational issues which drove X-37 toward the selection of a storable propulsion system. The design of storable propulsion systems offers the leveraging of hardware experience that can accelerate progress toward critical design. It also involves the experience gained from launching systems using MMH and N2O4 propellants. Leveraging of previously flight-qualified hardware may offer economic benefits and may reduce risk in cost and schedule. This paper summarizes recommendations based on experience gained from Space Shuttle and similar propulsion systems utilizing MMH and N2O4 propellants. System design insights gained from flying storable propulsion are presented and addressed in the context of the design approach of the X-37 propulsion system.

X-37 Storable Propulsion System Design and Operations

NASA Technical Reports Server (NTRS)

Rodriguez, Henry; Popp, Chris; Rehegan, Ronald J.

2006-01-01

In a response to NASA's X-37 TA-10 Cycle-1 contract, Boeing assessed nitrogen tetroxide (N2O4) and monomethyl hydrazine (MMH) Storable Propellant Propulsion Systems to select a low risk X-37 propulsion development approach. Space Shuttle lessons learned, planetary spacecraft, and Boeing Satellite HS-601 systems were reviewed to arrive at a low risk and reliable storable propulsion system. This paper describes the requirements, trade studies, design solutions, flight and ground operational issues which drove X-37 toward the selection of a storable propulsion system. The design of storable propulsion systems offers the leveraging of hardware experience that can accelerate progress toward critical design. It also involves the experience gained from launching systems using MMH and N2O4 propellants. Leveraging of previously flight-qualified hardware may offer economic benefits and may reduce risk in cost and schedule. This paper summarizes recommendations based on experience gained from Space Shuttle and similar propulsion systems utilizing MMH and N2O4 propellants. System design insights gained from flying storable propulsion are presented and addressed in the context of the design approach of the X-37 propulsion system.

Risk assessment and experimental design in the development of a prolonged release drug delivery system with paliperidone.

PubMed

Iurian, Sonia; Turdean, Luana; Tomuta, Ioan

2017-01-01

This study focuses on the development of a drug product based on a risk assessment-based approach, within the quality by design paradigm. A prolonged release system was proposed for paliperidone (Pal) delivery, containing Kollidon ® SR as an insoluble matrix agent and hydroxypropyl cellulose, hydroxypropyl methylcellulose (HPMC), or sodium carboxymethyl cellulose as a hydrophilic polymer. The experimental part was preceded by the identification of potential sources of variability through Ishikawa diagrams, and failure mode and effects analysis was used to deliver the critical process parameters that were further optimized by design of experiments. A D-optimal design was used to investigate the effects of Kollidon SR ratio ( X 1 ), the type of hydrophilic polymer ( X 2 ), and the percentage of hydrophilic polymer ( X 3 ) on the percentages of dissolved Pal over 24 h ( Y 1 - Y 9 ). Effects expressed as regression coefficients and response surfaces were generated, along with a design space for the preparation of a target formulation in an experimental area with low error risk. The optimal formulation contained 27.62% Kollidon SR and 8.73% HPMC and achieved the prolonged release of Pal, with low burst effect, at ratios that were very close to the ones predicted by the model. Thus, the parameters with the highest impact on the final product quality were studied, and safe ranges were established for their variations. Finally, a risk mitigation and control strategy was proposed to assure the quality of the system, by constant process monitoring.

An Analysis of Risk and Function Information in Early Stage Design

NASA Technical Reports Server (NTRS)

Barrientos, Francesca; Tumer, Irem; Grantham, Katie; VanWie, Michael; Stone, Robert

2005-01-01

The concept of function offers a high potential for thinking and reasoning about designs as well as providing a common thread for relating together other design information. This paper focuses specifically on the relation between function and risk by examining how this information is addressed for a design team conducting early stage design for space missions. Risk information is decomposed into a set of key attributes which are then used to scrutinize the risk information using three approaches from the pragmatics sub-field of linguistics: i) Gricean, ii) Relevance Theory, and Functional Analysis. Results of this linguistics-based approach descriptively account for the context of designer communication with respect to function and risk, and offer prescriptive guidelines for improving designer communication.

The Effects of Tai Chi on Cardiovascular Risk in Women.

PubMed

Robins, Jo Lynne; Elswick, R K; Sturgill, Jamie; McCain, Nancy L

2016-11-01

This study examined the effects of tai chi (TC) on biobehavioral factors associated with cardiovascular disease (CVD) risk in women. A randomized trial used a wait-list control group, pretest-posttest design. Data were collected immediately before, immediately after, and 2 months following the intervention. The study was community based in central Virginia. Women aged 35 to 50 years at increased risk for CVD. The 8-week intervention built on prior work and was designed to impact biobehavioral factors associated with CVD risk in women. Biological measures included fasting glucose, insulin, and lipids as well as C-reactive protein and cytokines. Behavioral measures included fatigue, perceived stress, depressive symptoms, social support, mindfulness, self-compassion, and spiritual thoughts and behaviors. A mixed effects linear model was used to test for differences between groups across time. In 63 women, TC was shown to decrease fatigue (∂ [difference in group means] = 9.38, p = .001) and granulocyte colony stimulating factor (∂ = 12.61, p = .052). Consistent with the study model and intervention design, significant changes observed 2 months post intervention indicated that TC may help down-regulate proinflammatory cytokines associated with underlying CVD risk, including interferon gamma (∂ = 149.90, p = .002), tumor necrosis factor (∂ = 16.78, p = .002), interleukin (IL) 8 (∂ = 6.47, p = .026), and IL-4 (∂ = 2.13, p = .001), and may increase mindfulness (∂ = .54, p = .021), spiritual thoughts and behaviors (∂ = 8.30, p = .009), and self-compassion (∂ = .44, p = .045). This study contributes important insights into the potential benefits and mechanisms of TC and, with further research, may ultimately lead to effective strategies for reducing CVD risk in women earlier in the CVD trajectory. © 2016 by American Journal of Health Promotion, Inc.

Application of the quality by design approach to the drug substance manufacturing process of an Fc fusion protein: towards a global multi-step design space.

PubMed

Eon-duval, Alex; Valax, Pascal; Solacroup, Thomas; Broly, Hervé; Gleixner, Ralf; Strat, Claire L E; Sutter, James

2012-10-01

The article describes how Quality by Design principles can be applied to the drug substance manufacturing process of an Fc fusion protein. First, the quality attributes of the product were evaluated for their potential impact on safety and efficacy using risk management tools. Similarly, process parameters that have a potential impact on critical quality attributes (CQAs) were also identified through a risk assessment. Critical process parameters were then evaluated for their impact on CQAs, individually and in interaction with each other, using multivariate design of experiment techniques during the process characterisation phase. The global multi-step Design Space, defining operational limits for the entire drug substance manufacturing process so as to ensure that the drug substance quality targets are met, was devised using predictive statistical models developed during the characterisation study. The validity of the global multi-step Design Space was then confirmed by performing the entire process, from cell bank thawing to final drug substance, at its limits during the robustness study: the quality of the final drug substance produced under different conditions was verified against predefined targets. An adaptive strategy was devised whereby the Design Space can be adjusted to the quality of the input material to ensure reliable drug substance quality. Finally, all the data obtained during the process described above, together with data generated during additional validation studies as well as manufacturing data, were used to define the control strategy for the drug substance manufacturing process using a risk assessment methodology. Copyright © 2012 Wiley-Liss, Inc.

The Effects of Vehicle Redesign on the Risk of Driver Death.

PubMed

Farmer, Charles M; Lund, Adrian K

2015-01-01

This study updates a 2006 report that estimated the historical effects of vehicle design changes on driver fatality rates in the United States, separate from the effects of environmental and driver behavior changes during the same period. In addition to extending the period covered by 8 years, this study estimated the effect of design changes by model year and vehicle type. Driver death rates for consecutive model years of vehicle models without design changes were used to estimate the vehicle aging effect and the death rates that would have been expected if the entire fleet had remained unchanged from the 1985 calendar year. These calendar year estimates are taken to be the combined effect of road environment and motorist behavioral changes, with the difference between them and the actual calendar year driver fatality rates reflecting the effect of changes in vehicle design and distribution of vehicle types. The effects of vehicle design changes by model year were estimated for cars, SUVs, and pickups by computing driver death rates for model years 1984-2009 during each of their first 3 full calendar years of exposure and comparing with the expected rates if there had been no design changes. As reported in the 2006 study, had there been no changes in the vehicle fleet, driver death risk would have declined during calendar years 1985-1993 and then slowly increased from 1993 to 2004. The updated results indicate that the gradual increase would have continued through 2006, after which driver fatality rates again would have declined through 2012. Overall, it is estimated that there were 7,700 fewer driver deaths in 2012 than there would have been had vehicle designs not changed. Cars were the first vehicle type whose design safety generally exceeded that of the 1984 model year (starting in model year 1996), followed by SUVs (1998 models) and pickups (2002 models). By the 2009 model year, car driver fatality risk had declined 51% from its high in 1994, pickup driver fatality risk had declined 61% from its high in 1988, and SUV risk had declined 79% from its high in 1988. The risk of driver death in 2009 model passenger vehicles was 8% lower than that in 2008 models and about half that in 1984 models. Changes in vehicles, whether from government regulations and consumer testing that led to advanced safety designs or from other factors such as consumer demand for different sizes and types of vehicles, have been key contributors to the decline in U.S. motor vehicle occupant crash death rates since the mid-1990s. Since the early 1990s, environmental and behavioral risk factors have not shown similar improvement, until the recession of 2007, even though there are many empirically proven countermeasures that have been inadequately applied.

Research design considerations for clinical studies of abuse-deterrent opioid analgesics: IMMPACT recommendations.

PubMed

Turk, Dennis C; O'Connor, Alec B; Dworkin, Robert H; Chaudhry, Amina; Katz, Nathaniel P; Adams, Edgar H; Brownstein, John S; Comer, Sandra D; Dart, Richard; Dasgupta, Nabarun; Denisco, Richard A; Klein, Michael; Leiderman, Deborah B; Lubran, Robert; Rappaport, Bob A; Zacny, James P; Ahdieh, Harry; Burke, Laurie B; Cowan, Penney; Jacobs, Petra; Malamut, Richard; Markman, John; Michna, Edward; Palmer, Pamela; Peirce-Sandner, Sarah; Potter, Jennifer S; Raja, Srinivasa N; Rauschkolb, Christine; Roland, Carl L; Webster, Lynn R; Weiss, Roger D; Wolf, Kerry

2012-10-01

Opioids are essential to the management of pain in many patients, but they also are associated with potential risks for abuse, overdose, and diversion. A number of efforts have been devoted to the development of abuse-deterrent formulations of opioids to reduce these risks. This article summarizes a consensus meeting that was organized to propose recommendations for the types of clinical studies that can be used to assess the abuse deterrence of different opioid formulations. Because of the many types of individuals who may be exposed to opioids, an opioid formulation will need to be studied in several populations using various study designs to determine its abuse-deterrent capabilities. It is recommended that the research conducted to evaluate abuse deterrence should include studies assessing: (1) abuse liability, (2) the likelihood that opioid abusers will find methods to circumvent the deterrent properties of the formulation, (3) measures of misuse and abuse in randomized clinical trials involving pain patients with both low risk and high risk of abuse, and (4) postmarketing epidemiological studies. Copyright © 2012 International Association for the Study of Pain. Published by Elsevier B.V. All rights reserved.

Design of a Family Study Among High-Risk Caribbean Hispanics: The Northern Manhattan Family Study

PubMed Central

Sacco, Ralph L.; Sabala, Edison A.; Rundek, Tanja; Juo, Suh-Hang Hank; Huang, Jinaping Sam; DiTullio, Marco; Homma, Shunichi; Almonte, Katihurka; Lithgow, Carlos García; Boden-Albala, Bernadette

2008-01-01

Stroke continues to kill disproportionately more Blacks and Hispanics than Whites in the United States. Racial/ethnic variations in the incidence of stroke and prevalence of stroke risk factors are probably explained by both genetic and environmental influences. Family studies can help identify genetic predisposition to stroke and potential stroke precursors. Few studies have evaluated the heritability of these stroke risk factors among non-White populations, and none have focused on Caribbean Hispanic populations. The aim of the Northern Manhattan Family Study (NOMAFS) is to investigate the gene-environment interaction of stroke risk factors among Caribbean Hispanics. The unique recruitment and methodologic approaches used in this study are relevant to the design and conduct of genetic aggregation studies to investigate complex genetic disorders in non-White populations. The aim of this paper is to describe the NOMAFS and report enrollment and characteristics of the participants. The NO-MAFS will provide a data resource for the exploration of the genetic determinants of highly heritable stroke precursor phenotypes that are less complex than the stroke phenotype. Understanding the gene environment interaction is the critical next step toward the development of new and unique approaches to disease prevention and interventions. PMID:17682370

[Four numbers and a bit more basic knowledge of mathematics].

PubMed

Günther, Judith; Briel, Matthias; Suter, Katja

2015-02-01

In addition to relative risk, relative risk reduction and absolute risk reduction there circulates another effect size for binary endpoints in the scientific medical literature: the odds ratio. Relative risk and odds ratio are alternative ways of reflecting study results. Both, relative risk (RR) and odds ratio (OR), can easily be calculated from the "2 x 2-table". Advantage of OR: odds ratios can be calculated in every type of controlled study design, including retrospective studies. Furthermore, odds ratios--the biostatisticians are swarming--offer beautiful mathematical properties and therefore are often used in meta-analysis as an effect size for calculating a pooled estimate of the results of different studies with the same clinical question. Disadvantage of OR: In clinical studies the presentation of the results as "odds ratios" may result in an overestimation of the intervention effect. This article shows the difference between "chance" and "risk" and how odds ratio and relative risk are associated.

Risk factors for stress fractures.

PubMed

Bennell, K; Matheson, G; Meeuwisse, W; Brukner, P

1999-08-01

Preventing stress fractures requires knowledge of the risk factors that predispose to this injury. The aetiology of stress fractures is multifactorial, but methodological limitations and expediency often lead to research study designs that evaluate individual risk factors. Intrinsic risk factors include mechanical factors such as bone density, skeletal alignment and body size and composition, physiological factors such as bone turnover rate, flexibility, and muscular strength and endurance, as well as hormonal and nutritional factors. Extrinsic risk factors include mechanical factors such as surface, footwear and external loading as well as physical training parameters. Psychological traits may also play a role in increasing stress fracture risk. Equally important to these types of analyses of individual risk factors is the integration of information to produce a composite picture of risk. The purpose of this paper is to critically appraise the existing literature by evaluating study design and quality, in order to provide a current synopsis of the known scientific information related to stress fracture risk factors. The literature is not fully complete with well conducted studies on this topic, but a great deal of information has accumulated over the past 20 years. Although stress fractures result from repeated loading, the exact contribution of training factors (volume, intensity, surface) has not been clearly established. From what we do know, menstrual disturbances, caloric restriction, lower bone density, muscle weakness and leg length differences are risk factors for stress fracture. Other time-honoured risk factors such as lower extremity alignment have not been shown to be causative even though anecdotal evidence indicates they are likely to play an important role in stress fracture pathogenesis.

Knee complaints and consequences on work status; a 10-year follow-up survey among floor layers and graphic designers.

PubMed

Rytter, Søren; Jensen, Lilli Kirkeskov; Bonde, Jens Peter

2007-09-18

The purpose of the study was to examine if knee complaints among floor layers predict exclusion from the trade. In 1994/95 self-reported data were obtained from a cohort of floor layers and graphic designers with and without knee straining work activities, respectively. At follow-up in 2005 the questionnaire survey was repeated. The study population consisted of 81 floor layers and 173 graphic designers who were presently working in their trades at baseline (1995). All participants were men aged 36-70 years in 2005. We computed the risk of losing gainful employment in the trade according to occurrence of knee complaints at baseline, using Cox proportional hazard regression adjusted for a number of potential confounding variables. Moreover, the crude and adjusted odds risk ratio for knee complaints according to status of employment in the trade were computed, using graphic designers as reference. A positive but non-significant association between knee complaints lasting more than 30 days the past 12 months and exclusion from the trade was found among floor layers (Hazard Ratio = 1.4, 95% CI = 0.6-3.5).The frequency of self-reported knee complaints was lower among floor layers presently at work in the trade in year 2005 (26.3%) compared with baseline in 1995 (41.1%), while the opposite tendency was seen among graphic designers (20.7% vs. 10.7%). The study suggests that knee complaints are a risk factor for premature exclusion from a knee demanding trade. However, low power of the study precludes strong conclusions. The study also indicates a healthy worker effect among floor layers and a survivor effect among graphic designers.

Knee complaints and consequences on work status; a 10-year follow-up survey among floor layers and graphic designers

PubMed Central

Rytter, Søren; Jensen, Lilli Kirkeskov; Bonde, Jens Peter

2007-01-01

Background The purpose of the study was to examine if knee complaints among floor layers predict exclusion from the trade. Methods In 1994/95 self-reported data were obtained from a cohort of floor layers and graphic designers with and without knee straining work activities, respectively. At follow-up in 2005 the questionnaire survey was repeated. The study population consisted of 81 floor layers and 173 graphic designers who were presently working in their trades at baseline (1995). All participants were men aged 36–70 years in 2005. We computed the risk of losing gainful employment in the trade according to occurrence of knee complaints at baseline, using Cox proportional hazard regression adjusted for a number of potential confounding variables. Moreover, the crude and adjusted odds risk ratio for knee complaints according to status of employment in the trade were computed, using graphic designers as reference. Results A positive but non-significant association between knee complaints lasting more than 30 days the past 12 months and exclusion from the trade was found among floor layers (Hazard Ratio = 1.4, 95% CI = 0.6–3.5). The frequency of self-reported knee complaints was lower among floor layers presently at work in the trade in year 2005 (26.3%) compared with baseline in 1995 (41.1%), while the opposite tendency was seen among graphic designers (20.7% vs. 10.7%). Conclusion The study suggests that knee complaints are a risk factor for premature exclusion from a knee demanding trade. However, low power of the study precludes strong conclusions. The study also indicates a healthy worker effect among floor layers and a survivor effect among graphic designers. PMID:17877790

HIV Risk Perception, HIV Knowledge, and Sexual Risk Behaviors among Transgender Women in South Florida.

PubMed

De Santis, Joseph P; Hauglum, Shayne D; Deleon, Diego A; Provencio-Vasquez, Elias; Rodriguez, Allan E

2017-05-01

Transgender women experience a variety of factors that may contribute to HIV risk. The purpose of this study was to explore links among HIV risk perception, knowledge, and sexual risk behaviors of transgender women. A descriptive, correlational study design was used. Fifty transgender women from the South Florida area were enrolled in the study. Transgender women completed a demographic questionnaire and standardized instruments measuring HIV risk perception, knowledge, and sexual risk behaviors. Transgender women reported low levels of HIV risk perception, and had knowledge deficits regarding HIV risk/transmission. Some participants engaged in high-risk sexual behaviors. Predictors of sexual risk behaviors among transgender women were identified. More research is needed with a larger sample size to continue studying factors that contribute to sexual risk behaviors in the understudied population of transgender women. Evidence-based guidelines are available to assist public health nurses in providing care for transgender women. Nurses must assess HIV perception risk and HIV knowledge and provide relevant education to transgender women on ways to minimize sexual risk. © 2016 Wiley Periodicals, Inc.

75 FR 59724 - Proposed Collection; Comment Request; Transfusion-Transmitted Retrovirus and Hepatitis Virus...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-28

...- control study design. (3) Determine nationally-representative infectious disease marker prevalence and... on current risk factors in blood donors as assessed using analytical study designs is largely... in first time donors increased. Moreover specific age, gender and race/ethnicity groups were over...

UTILITY DATA ARCHIVING FOR RISK MANAGEMENT

EPA Science Inventory

EPA let a contract for a consultant to collect information about historical changes in operations and maintenance, design and construction, and planning and siting for water and wastewater infrastructure. The goal of this research study is to determine risk management alternativ...

Multi-modal vehicle display design and analysis

DOT National Transportation Integrated Search

2004-10-01

There is increasing interest in systematically studying the risks encountered while driving. In some cases, the : focus is on potential risks such as those associated with the use of in-car devices (e.g., mobile phones, radio, navigational : displays...

17 CFR 1.73 - Clearing futures commission merchant risk management.

Code of Federal Regulations, 2014 CFR

2014-04-01

... maintain systems of risk controls reasonably designed to ensure compliance with the limits; (iii) When a... for clearing, it shall establish and maintain systems of risk management controls reasonably designed... maintain systems of risk management controls reasonably designed to ensure compliance with the limits. (v...

17 CFR 1.73 - Clearing futures commission merchant risk management.

Code of Federal Regulations, 2013 CFR

2013-04-01

... maintain systems of risk controls reasonably designed to ensure compliance with the limits; (iii) When a... for clearing, it shall establish and maintain systems of risk management controls reasonably designed... maintain systems of risk management controls reasonably designed to ensure compliance with the limits. (v...

Design standards for experimental and field studies to evaluate diagnostic accuracy of tests for infectious diseases in aquatic animals.

PubMed

Laurin, E; Thakur, K K; Gardner, I A; Hick, P; Moody, N J G; Crane, M S J; Ernst, I

2018-05-01

Design and reporting quality of diagnostic accuracy studies (DAS) are important metrics for assessing utility of tests used in animal and human health. Following standards for designing DAS will assist in appropriate test selection for specific testing purposes and minimize the risk of reporting biased sensitivity and specificity estimates. To examine the benefits of recommending standards, design information from published DAS literature was assessed for 10 finfish, seven mollusc, nine crustacean and two amphibian diseases listed in the 2017 OIE Manual of Diagnostic Tests for Aquatic Animals. Of the 56 DAS identified, 41 were based on field testing, eight on experimental challenge studies and seven on both. Also, we adapted human and terrestrial-animal standards and guidelines for DAS structure for use in aquatic animal diagnostic research. Through this process, we identified and addressed important metrics for consideration at the design phase: study purpose, targeted disease state, selection of appropriate samples and specimens, laboratory analytical methods, statistical methods and data interpretation. These recommended design standards for DAS are presented as a checklist including risk-of-failure points and actions to mitigate bias at each critical step. Adherence to standards when designing DAS will also facilitate future systematic review and meta-analyses of DAS research literature. © 2018 John Wiley & Sons Ltd.

Efficient discovery of risk patterns in medical data.

PubMed

Li, Jiuyong; Fu, Ada Wai-chee; Fahey, Paul

2009-01-01

This paper studies a problem of efficiently discovering risk patterns in medical data. Risk patterns are defined by a statistical metric, relative risk, which has been widely used in epidemiological research. To avoid fruitless search in the complete exploration of risk patterns, we define optimal risk pattern set to exclude superfluous patterns, i.e. complicated patterns with lower relative risk than their corresponding simpler form patterns. We prove that mining optimal risk pattern sets conforms an anti-monotone property that supports an efficient mining algorithm. We propose an efficient algorithm for mining optimal risk pattern sets based on this property. We also propose a hierarchical structure to present discovered patterns for the easy perusal by domain experts. The proposed approach is compared with two well-known rule discovery methods, decision tree and association rule mining approaches on benchmark data sets and applied to a real world application. The proposed method discovers more and better quality risk patterns than a decision tree approach. The decision tree method is not designed for such applications and is inadequate for pattern exploring. The proposed method does not discover a large number of uninteresting superfluous patterns as an association mining approach does. The proposed method is more efficient than an association rule mining method. A real world case study shows that the method reveals some interesting risk patterns to medical practitioners. The proposed method is an efficient approach to explore risk patterns. It quickly identifies cohorts of patients that are vulnerable to a risk outcome from a large data set. The proposed method is useful for exploratory study on large medical data to generate and refine hypotheses. The method is also useful for designing medical surveillance systems.

Study Design and Evaluation of Risk Minimization Measures: A Review of Studies Submitted to the European Medicines Agency for Cardiovascular, Endocrinology, and Metabolic Drugs.

PubMed

Mazzaglia, Giampiero; Straus, Sabine M J; Arlett, Peter; da Silva, Daniela; Janssen, Heidi; Raine, June; Alteri, Enrica

2018-02-01

Studies measuring the effectiveness of risk minimization measures (RMMs) submitted by pharmaceutical companies to the European Medicines Agency are part of the post-authorization regulatory requirements and represent an important source of data covering a range of medicinal products and safety-related issues. Their objectives, design, and the associated regulatory outcomes were reviewed, and conclusions were drawn that may support future progress in risk minimization evaluation. Information was obtained from risk management plans, study protocols, clinical study reports, and assessment reports of 157 medicinal products authorized for cardiovascular, endocrinology, and metabolic indications. We selected observational studies measuring, as outcomes of interest, the relationship between the RMMs in place and (1) implementation measures, such as clinical knowledge or physicians` compliance to recommendations contained in the RMMs; and (2) occurrence or reduced severity of the adverse drug reactions for which the RMMs were required. Of 59 eligible studies (24 completed, 35 ongoing), 44 assessed implementation measures, whereas only 15 assessed safety outcomes (1 study as a single endpoint and 14 studies with other endpoints). Fifty-one studies used non-experimental designs and 25 studies employed electronic healthcare databases for analysis. Of the 24 completed studies, 17 were considered satisfactory and supported immediate regulatory decision making, 6 were considered inconclusive and required new evaluations, and 1 was terminated early because new safety restrictions were required, thereby necessitating a new evaluation. Compliance with agreed deadlines was considered acceptable in 21 of 24 completed studies; the average time for a submission was 37 months (standard deviation ± 17), with differences observed by type of data source employed. Three important gaps in the evaluation plans of RMMs were identified: lack of early feedback on implementation, limited evaluation of safety outcomes, and inability to provide information on the effectiveness from an integrated measurement of different elements of a set of risk minimization tools. More robust evidence is needed to advance regulatory science and support more rapid adjustment of risk minimization strategies as needed.

When Risk Becomes Invisible in the Everyday Life of Day Care

ERIC Educational Resources Information Center

Villumsen, Anne Marie; Kristensen, Ole Steen

2016-01-01

Both the identification of children at risk in day care and multidisciplinary collaboration with other professions have a political focus. This study was designed as an organizational field study and attempts to establish a coherent practice of multidisciplinary collaboration between day care and social services. This article focuses on the…

Risk Factors Associated with Obesity in Children of Different Racial Backgrounds

ERIC Educational Resources Information Center

Urrutia-Rojas, Ximena; Ahmad, Naveed; Bayona, Manuel; Bae, Sejong; Rivers, Patrick A; Singh, Karan P

2008-01-01

Objective: The purpose of this study is to determine specific risk factors associated with obesity among African American, Hispanic and Caucasian children. Design: This is a cross-sectional study conducted on 1076 fifth grade children from 17 elementary schools at Fort Worth, Texas. Data were collected through questionnaires and physical…

Studying the Emergence of Autism Spectrum Disorders in High-Risk Infants: Methodological and Practical Issues

ERIC Educational Resources Information Center

Zwaigenbaum, Lonnie; Thurm, Audrey; Stone, Wendy; Baranek, Grace; Bryson, Susan; Iverson, Jana; Kau, Alice; Klin, Ami; Lord, Cathy; Landa, Rebecca; Rogers, Sally; Sigman, Marian

2007-01-01

Detecting early signs of autism is essential for timely diagnosis and initiation of effective interventions. Several research groups have initiated prospective studies of high-risk populations including infant siblings, to systematically collect data on early signs within a longitudinal design. Despite the potential advantages of prospective…

Inpatient Suicide in a Chinese Psychiatric Hospital

ERIC Educational Resources Information Center

Li, Jie; Ran, Mao-Sheng; Hao, Yuantao; Zhao, Zhenhuan; Guo, Yangbo; Su, Jinghua; Lu, Huixian

2008-01-01

Little is known about the risk factors for suicide among psychiatric inpatients in China. In this study we identified the risk factors of suicide among psychiatric inpatients at Guangzhou Psychiatric Hospital. All psychiatric inpatients who died by suicide during the 1956-2005 period were included in this study. Using a case-control design, 64…

Internet Addiction among Adolescence

ERIC Educational Resources Information Center

Sargin, Nurten

2012-01-01

Each innovation brings along many risks. One of the risks related with the Internet use is Internet addiction. The aim of this study is to examine Internet addiction in adolescence in terms of gender, Internet access at home and grades. The research design used was survey method. The study population consisted of second stage students attending…

An assessment of tailoring of lightning protection design requirements for a composite wing structure on a metallic aircraft

NASA Technical Reports Server (NTRS)

Harwood, T. L.

1991-01-01

The Navy A-6E aircraft is presently being modified with a new wing which uses graphite/epoxy structures and substructures around a titanium load-bearing structure. The ability of composites to conduct electricity is less than that of aluminum. This is cause for concern when the wing may be required to conduct large lightning currents. The manufacturer attempted to solve lightning protection issues by performing a risk assessment based on a statistical approach which allows relaxation of the wing lightning protection design levels over certain locations of the composite wing. A sensitivity study is presented designed to define the total risk of relaxation of the design levels.

CARING (CAncer Risk and INsulin analoGues): The Association of Diabetes Mellitus and Cancer Risk with Focus on Possible Determinants - A Systematic Review and a Meta-Analysis

PubMed Central

Starup-Linde, Jakob; Karlstad, Øystein; Eriksen, Stine Aistrup; Vestergaard, Peter; Bronsveld, Heleen K.; de Vries, Frank; Andersen, Morten; Auvinen, Anssi; Haukka, Jari; Hjellvik, Vidar; Bazelier, Marloes T.; de Boer, Anthonius; Furu, Kari; De Bruin, Marie L.

2013-01-01

Background: Patients suffering from diabetes mellitus (DM) may experience an increased risk of cancer; however, it is not certain whether this effect is due to diabetes per se. Objective: To examine the association between DM and cancers by a systematic review and meta-analysis according to the PRISMA guidelines. Data Sources: The systematic literature search includes Medline at PubMed, Embase, Cinahl, Bibliotek.dk, Cochrane library, Web of Science and SveMed+ with the search terms: “Diabetes mellitus”, “Neoplasms”, and “Risk of cancer”. Study Eligibility Criteria: The included studies compared the risk of cancer in diabetic patients versus non-diabetic patients. All types of observational study designs were included. Results: Diabetes patients were at a substantially increased risk of liver (RR=2.1), and pancreas (RR=2.2) cancer. Modestly elevated significant risks were also found for ovary (RR=1.2), breast (RR=1.1), cervix (RR=1.3), endometrial (RR=1.4), several digestive tract (RR=1.1-1.5), kidney (RR=1.4), and bladder cancer (RR=1.1). The findings were similar for men and women, and unrelated to study design. Meta-regression analyses showed limited effect modification of body mass index, and possible effect modification of age, gender, with some influence of study characteristics (population source, cancer- and diabetes ascertainment). Limitations: Publication bias seemed to be present. Only published data were used in the analyses. Conclusions: The systematic review and meta-analysis confirm the previous results of increased cancer risk in diabetes and extend this to additional cancer sites. Physicians in contact with patients with diabetes should be aware that diabetes patients are at an increased risk of cancer. PMID:24215312

Distracted Driving and Risk of Crash or Near-crash Involvement among Older Drivers using Naturalistic Driving Data with a Case-crossover Study Design.

PubMed

Huisingh, Carrie; Owsley, Cynthia; Levitan, Emily B; Irvin, Marguerite R; MacLennan, Paul; McGwin, Gerald

2018-05-17

The purpose of this study was to examine the association between secondary task involvement and risk of crash and near-crash involvement among older drivers using naturalistic driving data. Data from drivers aged ≥70 years in the Strategic Highway Research Program (SHRP2) Naturalistic Driving Study database was utilized. The personal vehicle of study participants was equipped with four video cameras enabling recording of the driver and the road environment. Secondary task involvement during a crash or near-crash event was compared to periods of non-crash involvement in a case-crossover study design. Conditional logistic regression was used to generate odds ratios (OR) and 95% confidence intervals (CI). Overall, engaging in any secondary task was not associated with crash (OR=0.94, 95% CI 0.68-1.29) or near-crash (OR=1.08, 95% CI 0.79-1.50) risk. The risk of a major crash event with cell phone use was 3.79 times higher than the risk with no cell phone use (95% CI 1.00-14.37). Other glances into the interior of the vehicle were associated with an increased risk of near-crash involvement (OR=2.55, 95% CI 1.24-5.26). Other distractions external to the vehicle were associated with a decreased risk of crash involvement (OR=0.53, 95% CI 0.30-0.94). Interacting with a passenger and talking/singing were not associated with crash or near-crash risk. Older drivers should avoid any cell phone use and minimize non-driving related eye glances towards the interior of the vehicle while driving. Certain types of events external to the vehicle are associated with a reduced crash risk among older drivers.

Socio-Ecological Risk Factors for Prime-Age Adult Death in Two Coastal Areas of Vietnam

PubMed Central

Kim, Deok Ryun; Ali, Mohammad; Thiem, Vu Dinh; Wierzba, Thomas F.

2014-01-01

Background Hierarchical spatial models enable the geographic and ecological analysis of health data thereby providing useful information for designing effective health interventions. In this study, we used a Bayesian hierarchical spatial model to evaluate mortality data in Vietnam. The model enabled identification of socio-ecological risk factors and generation of risk maps to better understand the causes and geographic implications of prime-age (15 to less than 45 years) adult death. Methods and Findings The study was conducted in two sites: Nha Trang and Hue in Vietnam. The study areas were split into 500×500 meter cells to define neighborhoods. We first extracted socio-demographic data from population databases of the two sites, and then aggregated the data by neighborhood. We used spatial hierarchical model that borrows strength from neighbors for evaluating risk factors and for creating spatially smoothed risk map after adjusting for neighborhood level covariates. The Markov chain Monte Carlo procedure was used to estimate the parameters. Male mortality was more than twice the female mortality. The rates also varied by age and sex. The most frequent cause of mortality was traffic accidents and drowning for men and traffic accidents and suicide for women. Lower education of household heads in the neighborhood was an important risk factor for increased mortality. The mortality was highly variable in space and the socio-ecological risk factors are sensitive to study site and sex. Conclusion Our study suggests that lower education of the household head is an important predictor for prime age adult mortality. Variability in socio-ecological risk factors and in risk areas by sex make it challenging to design appropriate intervention strategies aimed at decreasing prime-age adult deaths in Vietnam. PMID:24587031

Socio-ecological risk factors for prime-age adult death in two coastal areas of Vietnam.

PubMed

Kim, Deok Ryun; Ali, Mohammad; Thiem, Vu Dinh; Wierzba, Thomas F

2014-01-01

Hierarchical spatial models enable the geographic and ecological analysis of health data thereby providing useful information for designing effective health interventions. In this study, we used a Bayesian hierarchical spatial model to evaluate mortality data in Vietnam. The model enabled identification of socio-ecological risk factors and generation of risk maps to better understand the causes and geographic implications of prime-age (15 to less than 45 years) adult death. The study was conducted in two sites: Nha Trang and Hue in Vietnam. The study areas were split into 500×500 meter cells to define neighborhoods. We first extracted socio-demographic data from population databases of the two sites, and then aggregated the data by neighborhood. We used spatial hierarchical model that borrows strength from neighbors for evaluating risk factors and for creating spatially smoothed risk map after adjusting for neighborhood level covariates. The Markov chain Monte Carlo procedure was used to estimate the parameters. Male mortality was more than twice the female mortality. The rates also varied by age and sex. The most frequent cause of mortality was traffic accidents and drowning for men and traffic accidents and suicide for women. Lower education of household heads in the neighborhood was an important risk factor for increased mortality. The mortality was highly variable in space and the socio-ecological risk factors are sensitive to study site and sex. Our study suggests that lower education of the household head is an important predictor for prime age adult mortality. Variability in socio-ecological risk factors and in risk areas by sex make it challenging to design appropriate intervention strategies aimed at decreasing prime-age adult deaths in Vietnam.

Association between Soy Isoflavone Intake and Breast Cancer Risk for Pre- and Post-Menopausal Women: A Meta-Analysis of Epidemiological Studies

PubMed Central

Zheng, Yi; Wei, Shiqing; Li, Ye; Guo, Tong; Yin, Ping

2014-01-01

Background Conclusions drawn from meta-analyses on the association between soy isoflavone intake and breast cancer risk for pre- and post-menopausal women are not fully consistent. These meta-analyses did not explore the influence of different study designs on the pooled results on the basis of distinguishing between pre- and post-menopausal women. Methodology and Principal Findings We performed a meta-analysis of 35 studies which reported results of association between soy isoflavone intake and breast cancer risk for pre- and/or post-menopausal women, calculated pooled odds ratios and their 95% confidence intervals of pre- and post-menopausal women respectively, and further explored soy isoflavone-breast cancer association on the basis of considering different study regions and designs. Summary results suggested that soy isoflavone intake has a protective effect against breast cancer for both pre- and post-menopausal women. However, they are influenced by study design and region. Pooled ORs of studies carried out in Asian countries suggested that soy isoflavone’s protective effect exist in both pre- and post-menopausal women (OR = 0.59, 95%CI: 0.48–0.69 for premenopausal women; OR = 0.59, 95%CI: 0.44–0.74 for postmenopausal women). However, there are some differences between the results pooled from different study designs for women in Asian countries (test for consistency, P = 0.04). Pooled OR of studies on postmenopausal women in Western countries suggested that soy isoflavone intake has a marginally significant protective effect (OR = 0.92; 95%CI: 0.83∼1.00), but further analyses stratifying by study design found no statistically significant association. Conclusions We meta-analyzed more and newer research results, and separated women according to menopausal status to explore soy isoflavone-breast cancer association. We founded that soy isoflavone intake could lower the risk of breast cancer for both pre- and post-menopausal women in Asian countries. However, for women in Western countries, pre- or post-menopausal, there is no evidence to suggest an association between intake of soy isoflavone and breast cancer. PMID:24586662

Designing Visual Aids That Promote Risk Literacy: A Systematic Review of Health Research and Evidence-Based Design Heuristics.

PubMed

Garcia-Retamero, Rocio; Cokely, Edward T

2017-06-01

Background Effective risk communication is essential for informed decision making. Unfortunately, many people struggle to understand typical risk communications because they lack essential decision-making skills. Objective The aim of this study was to review the literature on the effect of numeracy on risk literacy, decision making, and health outcomes, and to evaluate the benefits of visual aids in risk communication. Method We present a conceptual framework describing the influence of numeracy on risk literacy, decision making, and health outcomes, followed by a systematic review of the benefits of visual aids in risk communication for people with different levels of numeracy and graph literacy. The systematic review covers scientific research published between January 1995 and April 2016, drawn from the following databases: Web of Science, PubMed, PsycINFO, ERIC, Medline, and Google Scholar. Inclusion criteria were investigation of the effect of numeracy and/or graph literacy, and investigation of the effect of visual aids or comparison of their effect with that of numerical information. Thirty-six publications met the criteria, providing data on 27,885 diverse participants from 60 countries. Results Transparent visual aids robustly improved risk understanding in diverse individuals by encouraging thorough deliberation, enhancing cognitive self-assessment, and reducing conceptual biases in memory. Improvements in risk understanding consistently produced beneficial changes in attitudes, behavioral intentions, trust, and healthy behaviors. Visual aids were found to be particularly beneficial for vulnerable and less skilled individuals. Conclusion Well-designed visual aids tend to be highly effective tools for improving informed decision making among diverse decision makers. We identify five categories of practical, evidence-based guidelines for heuristic evaluation and design of effective visual aids.

Factors Influencing Cancer Risk Perception in High Risk Populations: A Systematic Review

PubMed Central

2011-01-01

Background Patients at higher than average risk of heritable cancer may process risk information differently than the general population. However, little is known about clinical, demographic, or psychosocial predictors that may impact risk perception in these groups. The objective of this study was to characterize factors associated with perceived risk of developing cancer in groups at high risk for cancer based on genetics or family history. Methods We searched Ovid MEDLINE, Ovid Embase, Ovid PsycInfo, and Scopus from inception through April 2009 for English-language, original investigations in humans using core concepts of "risk" and "cancer." We abstracted key information and then further restricted articles dealing with perceived risk of developing cancer due to inherited risk. Results Of 1028 titles identified, 53 articles met our criteria. Most (92%) used an observational design and focused on women (70%) with a family history of or contemplating genetic testing for breast cancer. Of the 53 studies, 36 focused on patients who had not had genetic testing for cancer risk, 17 included studies of patients who had undergone genetic testing for cancer risk. Family history of cancer, previous prophylactic tests and treatments, and younger age were associated with cancer risk perception. In addition, beliefs about the preventability and severity of cancer, personality factors such as "monitoring" personality, the ability to process numerical information, as well as distress/worry also were associated with cancer risk perception. Few studies addressed non-breast cancer or risk perception in specific demographic groups (e.g. elderly or minority groups) and few employed theory-driven analytic strategies to decipher interrelationships of factors. Conclusions Several factors influence cancer risk perception in patients at elevated risk for cancer. The science of characterizing and improving risk perception in cancer for high risk groups, although evolving, is still relatively undeveloped in several key topic areas including cancers other than breast and in specific populations. Future rigorous risk perception research using experimental designs and focused on cancers other than breast would advance the field. PMID:21595959

Risk Diagnosis for the Development of Social Behaviour Disorders in Pre-school Children.

ERIC Educational Resources Information Center

Butollo, W.

This paper is a summary of a study concerned with identification of risk variables which affect the development of social and emotional behavior in young children. Families with pre-schoolers responded to a questionnaire designed to screen children who might be considered high risk. The screening results were validated with behavior observations…

Tracing Differential Pathways of Risk: Associations among Family Adversity, Cortisol, and Cognitive Functioning in Childhood

ERIC Educational Resources Information Center

Suor, Jennifer H.; Sturge-Apple, Melissa L.; Davies, Patrick T.; Cicchetti, Dante; Manning, Liviah G.

2015-01-01

Guided by family risk and allostasis theoretical frameworks, the present study utilized a prospective longitudinal design to examine associations among family risk experiences, basal cortisol patterns, and cognitive functioning in children. The sample included 201 low-income children living within a midsize city in the Northeastern United States.…

Cardiac Assessment Risk Evaluation (Care Study) of African American College Women

ERIC Educational Resources Information Center

Brown, Sandra C.; Geiselman, Paula J.; Copeland, Amy L.; Gordon, Carol; Dudley, Mary; Manogin, Toni; Backstedt, Carol; Pourciau, Cathi; Ghebretatios, Ghenet

2005-01-01

Objective: To identify physiological and psychosocial variables of young African American women that may serve as a risk factor for heart disease and to assess their health promotion programme preferences. Method: A descriptive design was used to assess the cardiovascular risk factors of 100 African American women ages 18 to 40 years, enrolled in…

Actual versus Perceived Risk of Cervical Cancer among College Women Smokers

ERIC Educational Resources Information Center

Saules, Karen K.; Vannest, Neo O.; Mehringer, Ann M.; Pomerleau, Cynthia S.; Lee, Keleigh; Opipari, Anthony W.; Midgley, A. Rees; Kleinsmith, Lewis J.; Sen, Ananda; Snedecor, Sandy M.

2007-01-01

Cervical cancer is a well-established smoking-related illness, but many at-risk women are unaware of this link. Objective: The authors designed this study to (1) investigate the relationship of smoking behavior with the history of abnormal Pap test results, sexual history, and perceived risk of cervical cancer and (2) determine whether…

The Effects of an Academic Alternative High School on Academically At-Risk Students

ERIC Educational Resources Information Center

Winningham, Mark L.

2012-01-01

In a causal-comparative research design, this study investigated the effectiveness of an academic alternative school in improving at-risk student outcomes in a selected county school system in the Upper Cumberland region of Tennessee. The academic alternative high school was compared to a traditional high school serving at-risk populations.…

Neural Correlates of Traditional Chinese Medicine Induced Advantageous Risk-Taking Decision Making

ERIC Educational Resources Information Center

Lee, Tiffany M. Y.; Guo, Li-guo; Shi, Hong-zhi; Li, Yong-zhi; Luo, Yue-jia; Sung, Connie Y. Y.; Chan, Chetwyn C. H.; Lee, Tatia M. C.

2009-01-01

This fMRI study examined the neural correlates of the observed improvement in advantageous risk-taking behavior, as measured by the number of adjusted pumps in the Balloon Analogue Risk Task (BART), following a 60-day course of a Traditional Chinese Medicine (TCM) recipe, specifically designed to regulate impulsiveness in order to modulate…

Predictors of Shunt-dependent Hydrocephalus After Aneurysmal Subarachnoid Hemorrhage? A Systematic Review and Meta-Analysis.

PubMed

Xie, Zhiyi; Hu, Xin; Zan, Xin; Lin, Sen; Li, Hao; You, Chao

2017-10-01

Hydrocephalus is a well-recognized complication after aneurysmal subarachnoid hemorrhage (aSAH). This study aimed to identify predictors for shunt-dependent hydrocephalus (SDHC) after aSAH via a systematic review and meta-analysis. A systematic search was conducted using the Embase, MEDLINE, and Web of Science databases for studies pertaining to aSAH and SDHC. Risk factors were assessed by meta-analysis when they were reported by at least 2 studies. The results were presented as odd ratios or risk ratios according to the study design with the corresponding 95% confidence intervals (CI). Twenty-five studies were included. In primary analysis of 14 potential risk factors, 12 were identified as predictors of SDHC after aSAH including age ≥50 years, female gender, high Hunt-Hess grade, Glasgow Coma Scale ≤8, Fisher grade ≥3, acute hydrocephalus, external ventricular drainage insertion, intraventricular hemorrhage, postcirculation aneurysm, anterior communicating artery aneurysm, meningitis, and rebleeding. The meta-analysis based on cohort studies found a significantly increased risk for SDHC in patients with aSAH treated by coiling (risk ratio, 1.16; 95% CI, 1.05-1.29), while the meta-analysis based on case-controlled studies failed to replicate this finding (odds ratio, 1.27; 95% CI, 0.95-1.71). Several new predictors of SDHC after aSAH were identified that may assist with the early recognition and prevention of SDHC. The controversial evidence found in this study was insufficient to support the potential of neurosurgical clipping for reducing the risk of shunt dependency. Further well-designed studies are warranted to explore the effect of treatment modality on SDHC risk. Copyright © 2017 Elsevier Inc. All rights reserved.

Facilitating Literacy Acquisition in At-Risk Second-Grade Students Using a Rhythmic Intervention: A Case Study

ERIC Educational Resources Information Center

Jones-Gensel, Deborah May

2016-01-01

The purpose of this intrinsic, holistic case study was to describe and analyze the impact of a rhythmic intervention designed to support literacy skills in second-grade students at-risk of failure of state mandated reading assessment. The theories used to guide this study were Finkelstein (2001) and Hunt's (1966) disability theory, and critical…

Intertwining Risk Insights and Design Decisions

NASA Technical Reports Server (NTRS)

Cornford, Steven L.; Feather, Martin S.; Jenkins, J. Steven

2006-01-01

The state of systems engineering is such that a form of early and continued use of risk assessments is conducted (as evidenced by NASA's adoption and use of the 'Continuous Risk Management' paradigm developed by SEI). ... However, these practices fall short of theideal: (1) Integration between risk assessment techniques and other systems engineering tools is weak. (2) Risk assessment techniques and the insights they yield are only informally coupled to design decisions. (3) Individual riskassessment techniques lack the mix of breadth, fidelity and agility required to span the gamut of the design space. In this paper we present an approach that addresses these shortcomings. The hallmark of our approach is a simple representation comprising objectives (what the system is to do), risks (whose occurrence would detract from attainment of objectives) and activities (a.k.a. 'mitigations') that, if performed, will decrease those risks. These are linked to indicate by how much a risk would detract from attainment of an objective, and by how much an activity would reduce a risk. The simplicity of our representational framework gives it the breadth to encompass the gamut of the design space concerns, the agility to be utilized in even the earliest phases of designs, and the capability to connect to system engineering models and higher-fidelity risk tools. It is through this integration that we address the shortcomings listed above, and so achieve the intertwining between risk insights and design decisions needed to guide systems engineering towards superior final designs while avoiding costly rework to achieve them. The paper will use an example, constructed to be representative of space mission design, to illustrate our approach.

Bringing Back a Healthy Buzz? Invertebrate Parasites and Reintroductions: A Case Study in Bumblebees.

PubMed

Brown, Mark J F; Sainsbury, Anthony W; Vaughan-Higgins, Rebecca J; Measures, Gavin H; Jones, Catherine M; Gammans, Nikki

2017-03-01

Reintroductions can play a key role in the conservation of endangered species. Parasites may impact reintroductions, both positively and negatively, but few case studies of how to manage parasites during reintroductions exist. Bumblebees are in decline at regional and global scales, and reintroductions can be used to re-establish extinct local populations. Here we report on how the risks associated with parasites are being managed in an ongoing reintroduction of the short-haired bumblebee, Bombus subterraneus, to the UK. Disease risk analysis was conducted and disease risk management plans constructed to design a capture-quarantine-release system that minimised the impacts on both the bumblebees and on their natural parasites. Given that bumblebee parasites are (i) generalists, (ii) geographically ubiquitous, and (iii) show evidence of local adaptation, the disease risk management plan was designed to limit the co-introduction of parasites from the source population in Sweden to the destination site in the UK. Results suggest that this process at best eliminated, or at least severely curtailed the co-introduction of parasites, and ongoing updates of the plan enabled minimization of impacts on natural host-parasite dynamics in the Swedish source population. This study suggests that methods designed for reintroductions of vertebrate species can be successfully applied to invertebrates. Future reintroductions of invertebrates where the parasite fauna is less well known should take advantage of next-generation barcoding and multiple survey years prior to the start of reintroductions, to develop comprehensive disease risk management plans.

Musculoskeletal Problems in Iranian Hand-Woven Shoe-Sole Making Operation and Developing Guidelines for Workstation Design.

PubMed

Veisi, H; Choobineh, A R; Ghaem, H

2016-04-01

Musculoskeletal disorders (MSDs) are among important health problems in working population. Because of performing difficult physical activities, hand-woven shoe-sole makers are at risk of developing various types of MSDs. To determine the prevalence of musculoskeletal symptoms in different body areas of hand-woven shoe-sole makers, assess workers' postures and workstations, evaluate ergonomic and individual factors associated with MSDs, and develop guidelines for designing hand-woven shoe-sole making workstation. In this cross-sectional study, the prevalence of MSDs symptoms and their risk factors were studied among 240 hand-woven shoe-sole makers. Working posture and workstations were ergonomically assessed as well. The data were collected through interviewing and using Nordic musculoskeletal questionnaire and by direct observation of posture using RULA method. Logistic regression analysis was used to determine risk factors associated with MSDs symptoms. The prevalence and severity of MSDs symptoms were high among the study population. Ergonomic factors including daily working time, working posture, and force exertion, as well as individual factors, such as age, job tenure, and education were significantly associated with MSDs symptoms. It seems that the majority of ergonomics shortcomings originate from poorly designed workstation. Some general guidelines for designing shoe-sole making workstation are presented.

Long-Term Unemployment and Suicide: A Systematic Review and Meta-Analysis

PubMed Central

Milner, Allison; Page, Andrew; LaMontagne, Anthony D.

2013-01-01

Purpose There have been a number of reviews on the association+ between unemployment and suicide, but none have investigated how this relationship is influenced by duration of unemployment. Method A systematic review and meta-analysis was conducted of those studies that assessed duration of unemployment as a risk factor for suicide. Studies considered as eligible for inclusion were population-based cohort or case-control designs; population-based ecological designs, or hospital based clinical cohort or case-control designs published in the year 1980 or later. Results The review identified 16 eligible studies, out of a possible 10,358 articles resulting from a search of four databases: PubMed, Web of Knowledge, Scopus and Proquest. While all 16 studies measured unemployment duration in different ways, a common finding was that longer duration of unemployment was related to greater risk of suicide and suicide attempt. A random effects meta-analysis on a subsample of six cohort studies indicated that the pooled relative risk of suicide in relation to average follow-up time after unemployment was 1.70 (95% CI 1.22 to 2.18). However, results also suggested a possible habituation effect to unemployment over time, with the greatest risk of suicide occurring within five years of unemployment compared to the employed population (RR = 2.50, 95% CI 1.83 to 3.17). Relative risk appeared to decline in studies of those unemployed between 12 and 16 years compared to those currently employed (RR = 1.21, 95% CI 1.10 to 1.33). Conclusion Findings suggest that long-term unemployment is associated with greater incidence of suicide. Results of the meta-analysis suggest that risk is greatest in the first five years, and persists at a lower but elevated level up to 16 years after unemployment. These findings are limited by the paucity of data on this topic. PMID:23341881

77 FR 47924 - Determinations Concerning Illnesses Discussed in National Academy of Sciences Report: Veterans...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-10

... significant increased prevalence of hypertension. The cross-sectional design of this study (in which subjects.... This study was also cross-sectional in design, limiting its ability to quantify risk, establish a... for significant confounders or by other methodological concerns. Accordingly, [[Page 47927

Rationale, design and methods of the HEALTHY study physical education intervention component

USDA-ARS?s Scientific Manuscript database

The HEALTHY primary prevention trial was designed to reduce risk factors for type 2 diabetes in middle school students. Middle schools at seven centers across the United States participated in the 3-year study. Half of them were randomized to receive a multi-component intervention. The intervention ...

Fundamentals of Sports Analytics.

PubMed

Wasserman, Erin B; Herzog, Mackenzie M; Collins, Christy L; Morris, Sarah N; Marshall, Stephen W

2018-07-01

Recently, the importance of statistics and analytics in sports has increased. This review describes measures of sports injury and fundamentals of sports injury research with a brief overview of some of the emerging measures of sports performance. We describe research study designs that can be used to identify risk factors for injury, injury surveillance programs, and common measures of injury risk and association. Finally, we describe measures of physical performance and training and considerations for using these measures. This review provides sports medicine clinicians with an understanding of current research measures and considerations for designing sports injury research studies. Copyright © 2018 Elsevier Inc. All rights reserved.

Towards responsible system development in health services: a discourse analysis study of design conflict resolution tactics.

PubMed

Irestig, Magnus; Timpka, Toomas

2010-02-01

We set out to examine design conflict resolution tactics used in development of large information systems for health services and to outline the design consequences for these tactics. Discourse analysis methods were applied to data collected from meetings conducted during the development of a web-based system in a public health context. We found that low risk tactics were characterized by design issues being managed within the formal mandate and competences of the design group. In comparison, high risk tactics were associated with irresponsible compromises, i.e. decisions being passed on to others or to later phases of the design process. The consequence of this collective disregard of issues such as responsibility and legitimacy is that the system design will be impossible to implement in factual health service contexts. The results imply that downstream responsibility issues have to be continuously dealt with in system development in health services.

Managing Large Scale Project Analysis Teams through a Web Accessible Database

NASA Technical Reports Server (NTRS)

O'Neil, Daniel A.

2008-01-01

Large scale space programs analyze thousands of requirements while mitigating safety, performance, schedule, and cost risks. These efforts involve a variety of roles with interdependent use cases and goals. For example, study managers and facilitators identify ground-rules and assumptions for a collection of studies required for a program or project milestone. Task leaders derive product requirements from the ground rules and assumptions and describe activities to produce needed analytical products. Disciplined specialists produce the specified products and load results into a file management system. Organizational and project managers provide the personnel and funds to conduct the tasks. Each role has responsibilities to establish information linkages and provide status reports to management. Projects conduct design and analysis cycles to refine designs to meet the requirements and implement risk mitigation plans. At the program level, integrated design and analysis cycles studies are conducted to eliminate every 'to-be-determined' and develop plans to mitigate every risk. At the agency level, strategic studies analyze different approaches to exploration architectures and campaigns. This paper describes a web-accessible database developed by NASA to coordinate and manage tasks at three organizational levels. Other topics in this paper cover integration technologies and techniques for process modeling and enterprise architectures.

A matched case-control study of convenience store robbery risk factors.

PubMed

Hendricks, S A; Landsittel, D P; Amandus, H E; Malcan, J; Bell, J

1999-11-01

Convenience store clerks have been shown to be at high risk for assault and homicide, mostly owing to robbery or robbery attempts. Although the literature consistently indicates that at least some environmental designs are effective deterrents of robbery, the significance of individual interventions and policies has differed across past studies. To address these issues, a matched case-control study of 400 convenience store robberies in three metropolitan areas of Virginia was conducted. Conditional logistic regression was implemented to evaluate the significance of various environmental designs and other factors possibly related to convenience store robbery. Findings indicate that numerous characteristics of the surrounding environment and population were significantly associated with convenience store robbery. Results also showed that, on a univariate level, most crime prevention factors were significantly associated with a lower risk for robbery. Using a forward selection process, a multivariate model, which included cash handling policy, bullet-resistant shielding, and numerous characteristics of the surrounding area and population, was identified. This study addressed numerous limitations of the previous literature by prospectively collecting extensive data on a large sample of diverse convenience stores and directly addressing the current theory on the robbers' selection of a target store through a matched case-control design.

Case–control and prospective studies of dietary α-linolenic acid intake and prostate cancer risk: a meta-analysis

PubMed Central

Carleton, Amanda J; Sievenpiper, John L; de Souza, Russell; McKeown-Eyssen, Gail; Jenkins, David J A

2013-01-01

Objective α-Linolenic acid (ALA) is considered to be a cardioprotective nutrient; however, some epidemiological studies have suggested that dietary ALA intake increases the risk of prostate cancer. The main objective was to conduct a systematic review and meta-analysis of case–control and prospective studies investigating the association between dietary ALA intake and prostate cancer risk. Design A systematic review and meta-analysis were conducted by searching MEDLINE and EMBASE for relevant prospective and case–control studies. Included studies We included all prospective cohort, case–control, nested case-cohort and nested case–control studies that investigated the effect of dietary ALA intake on the incidence (or diagnosis) of prostate cancer and provided relative risk (RR), HR or OR estimates. Primary outcome measure Data were pooled using the generic inverse variance method with a random effects model from studies that compared the highest ALA quantile with the lowest ALA quantile. Risk estimates were expressed as RR with 95% CIs. Heterogeneity was assessed by χ2 and quantified by I2. Results Data from five prospective and seven case–control studies were pooled. The overall RR estimate showed ALA intake to be positively but non-significantly associated with prostate cancer risk (1.08 (0.90 to 1.29), p=0.40; I2=85%), but the interpretation was complicated by evidence of heterogeneity not explained by study design. A weak, non-significant protective effect of ALA intake on prostate cancer risk in the prospective studies became significant (0.91 (0.83 to 0.99), p=0.02) without evidence of heterogeneity (I2=8%, p=0.35) on removal of one study during sensitivity analyses. Conclusions This analysis failed to confirm an association between dietary ALA intake and prostate cancer risk. Larger and longer observational and interventional studies are needed to define the role of ALA and prostate cancer. PMID:23674441

Do consanguineous parents of a child affected by an autosomal recessive disease have more DNA identical-by-descent than similarly-related parents with healthy offspring? Design of a case-control study

PubMed Central

2010-01-01

Background The offspring of consanguineous relations have an increased risk of congenital/genetic disorders and early mortality. Consanguineous couples and their offspring account for approximately 10% of the global population. The increased risk for congenital/genetic disorders is most marked for autosomal recessive disorders and depends on the degree of relatedness of the parents. For children of first cousins the increased risk is 2-4%. For individual couples, however, the extra risk can vary from zero to 25% or higher, with only a minority of these couples having an increased risk of at least 25%. It is currently not possible to differentiate between high-and low-risk couples. The quantity of DNA identical-by-descent between couples with the same degree of relatedness shows a remarkable variation. Here we hypothesize that consanguineous partners with children affected by an autosomal recessive disease have more DNA identical-by-descent than similarly-related partners who have only healthy children. The aim of the study is thus to establish whether the amount of DNA identical-by-descent in consanguineous parents of children with an autosomal recessive disease is indeed different from its proportion in consanguineous parents who have healthy children only. Methods/Design This project is designed as a case-control study. Cases are defined as consanguineous couples with one or more children with an autosomal recessive disorder and controls as consanguineous couples with at least three healthy children and no affected child. We aim to include 100 case couples and 100 control couples. Control couples are matched by restricting the search to the same family, clan or ethnic origin as the case couple. Genome-wide SNP arrays will be used to test our hypothesis. Discussion This study contains a new approach to risk assessment in consanguineous couples. There is no previous study on the amount of DNA identical-by-descent in consanguineous parents of affected children compared to the consanguineous parents of healthy children. If our hypothesis proves to be correct, further studies are needed to obtain different risk figure estimates for the different proportions of DNA identical-by-descent. With more precise information about their risk status, empowerment of couples can be improved when making reproductive decisions. PMID:20637082

Is gender still a predisposing factor in contrast-media associated adverse drug reactions? A systematic review and meta-analysis of randomized trials and observational studies.

PubMed

Lee, Heeyoung; Song, Seungyeon; Oh, Yun-Kyoung; Kang, WonKu; Kim, Eunyoung

2017-04-01

To evaluate the role of gender as a risk factor for developing contrast media-associated adverse drug reactions (CM-ADRs) by comparing the incidence of CM-ADR between male and female patients according to study design, ADR type, and computed tomography (CT) examination. We systematically searched three electronic databases for eligible studies. In the studies included (n=18), we assessed effect estimates of the relative incidence of CM-ADR, analysed by experimental design, ADR type and CT examination. This was calculated by using a random effects model if clinical conditions showed heterogeneity; otherwise, a fixed effects model was used. We identified 10,776 patients administered CM. According to the designs, studies were classified into randomised controlled trials (RCTs) and observational studies. Results were as follows: risk ratio (RR)=1.07 (95% confidence interval (CI): 0.79-1.46, P=0.66) for RCTs, and RR=0.77 (95% CI: 0.58-1.04, P=0.09) for observational studies. The results of analysis according to ADR type and for undergoing CT demonstrated that the incidence of CM-ADR did not differ between males and females. We found no significant difference in the incidence of CM-ADRs between male and female patients according to study design, ADR type, or CT examination. Future studies to determine why gender has shown different roles as a risk factor between CM-ADRs and non-CM ADRs are needed. Copyright © 2017 Elsevier B.V. All rights reserved.

Aircraft Conceptual Design and Risk Analysis Using Physics-Based Noise Prediction

NASA Technical Reports Server (NTRS)

Olson, Erik D.; Mavris, Dimitri N.

2006-01-01

An approach was developed which allows for design studies of commercial aircraft using physics-based noise analysis methods while retaining the ability to perform the rapid trade-off and risk analysis studies needed at the conceptual design stage. A prototype integrated analysis process was created for computing the total aircraft EPNL at the Federal Aviation Regulations Part 36 certification measurement locations using physics-based methods for fan rotor-stator interaction tones and jet mixing noise. The methodology was then used in combination with design of experiments to create response surface equations (RSEs) for the engine and aircraft performance metrics, geometric constraints and take-off and landing noise levels. In addition, Monte Carlo analysis was used to assess the expected variability of the metrics under the influence of uncertainty, and to determine how the variability is affected by the choice of engine cycle. Finally, the RSEs were used to conduct a series of proof-of-concept conceptual-level design studies demonstrating the utility of the approach. The study found that a key advantage to using physics-based analysis during conceptual design lies in the ability to assess the benefits of new technologies as a function of the design to which they are applied. The greatest difficulty in implementing physics-based analysis proved to be the generation of design geometry at a sufficient level of detail for high-fidelity analysis.

Do behavioral scientists really understand HIV-related sexual risk behavior? A systematic review of longitudinal and experimental studies predicting sexual behavior.

PubMed

Huebner, David M; Perry, Nicholas S

2015-10-01

Behavioral interventions to reduce sexual risk behavior depend on strong health behavior theory. By identifying the psychosocial variables that lead causally to sexual risk, theories provide interventionists with a guide for how to change behavior. However, empirical research is critical to determining whether a particular theory adequately explains sexual risk behavior. A large body of cross-sectional evidence, which has been reviewed elsewhere, supports the notion that certain theory-based constructs (e.g., self-efficacy) are correlates of sexual behavior. However, given the limitations of inferring causality from correlational research, it is essential that we review the evidence from more methodologically rigorous studies (i.e., longitudinal and experimental designs). This systematic review identified 44 longitudinal studies in which investigators attempted to predict sexual risk from psychosocial variables over time. We also found 134 experimental studies (i.e., randomized controlled trials of HIV interventions), but of these only 9 (6.7 %) report the results of mediation analyses that might provide evidence for the validity of health behavior theories in predicting sexual behavior. Results show little convergent support across both types of studies for most traditional, theoretical predictors of sexual behavior. This suggests that the field must expand the body of empirical work that utilizes the most rigorous study designs to test our theoretical assumptions. The inconsistent results of existing research would indicate that current theoretical models of sexual risk behavior are inadequate, and may require expansion or adaptation.

Meat consumption and risk of lung cancer: evidence from observational studies

PubMed Central

Yang, W. S.; Wong, M. Y.; Vogtmann, E.; Tang, R. Q.; Xie, L.; Yang, Y. S.; Wu, Q. J.; Zhang, W.; Xiang, Y. B.

2012-01-01

Background A number of epidemiological studies have reported inconsistent findings on the association between meat consumption and lung cancer. Design We therefore conducted a systematic review and meta-analysis to investigate the relationship between meat consumption and lung cancer risk in epidemiological studies. Results Twenty-three case–control and 11 cohort studies were included. All studies adjusted for smoking or conducted in never smokers. The summary relative risks (RRs) of lung cancer for the highest versus lowest intake categories were 1.35 (95% confidence interval (CI) 1.08–1.69) for total meat, 1.34 (95% CI 1.18–1.52) for red meat, and 1.06 (95% CI 0.90–1.25) for processed meat. An inverse association was found between poultry intake and lung cancer (RR = 0.91, 95% CI 0.85–0.97), but not for total white meat (RR = 1.06, 95% CI 0.82–1.37) or fish (RR = 1.01, 95% CI 0.96–1.07). Conclusions The relationship between meat intake and lung cancer risk appears to depend on the types of meat consumed. A high intake of red meat may increase the risk of lung cancer by about 35%, while a high intake of poultry decreases the risk by about 10%. More well-designed cohort studies on meat mutagens or heme iron, meat cooking preferences, and doneness level are needed to fully characterize this meat–lung cancer association. PMID:22855553

Above, Beyond, and Over the Side rails: Evaluating the New Memorial Emergency Department Fall-Risk-Assessment Tool.

PubMed

Scott, Robin A; Oman, Kathleen S; Flarity, Kathleen; Comer, Jennifer L

2018-03-06

Patient falls are a significant issue in hospitalized patients and financially costly to hospitals. The Joint Commission requires that patients be assessed for fall risk and interventions in place to mitigate the risk of falls. It is imperative to have a patient population/setting specific fall risk assessment tool to identify patients at risk for falling. The purpose of this study was to evaluate the reliability and validity of the 2013 Memorial ED Fall Risk Assessment tool (MEDFRAT) specifically designed for the ED population. A two-phase prospective design was used for this study. Phase one determined the interrater reliability of the MEDFRAT. Phase two assessed the validity of the MEDFRAT in an emergency department (ED) within a 600-bed academic/teaching institution; Level II Trauma Center with >100,000 annual patient visits. The Memorial ED Fall Risk Assessment Tool was validated in this ED setting. The tool demonstrated positive interrater reliability (k=0.701) and when implemented with a falls prevention strategy and staff education demonstrated a 48% decrease in ED fall rate (0.57 falls/1000 patient visits) post implementation during the study period. The MEDFRAT, an evidenced based ED-specific fall risk tool was implemented on the basis of the risk factors consistently identified in the literature: prior fall history, impaired mobility, altered mental status, altered elimination, and the use of sedative medication. The Memorial ED Fall Risk Assessment Tool demonstrated to be a valid tool for this hospital system. Copyright © 2018 Emergency Nurses Association. Published by Elsevier Inc. All rights reserved.

Communicating Low-Probability High-Consequence Risk, Uncertainty and Expert Confidence: Induced Seismicity of Deep Geothermal Energy and Shale Gas.

PubMed

Knoblauch, Theresa A K; Stauffacher, Michael; Trutnevyte, Evelina

2018-04-01

Subsurface energy activities entail the risk of induced seismicity including low-probability high-consequence (LPHC) events. For designing respective risk communication, the scientific literature lacks empirical evidence of how the public reacts to different written risk communication formats about such LPHC events and to related uncertainty or expert confidence. This study presents findings from an online experiment (N = 590) that empirically tested the public's responses to risk communication about induced seismicity and to different technology frames, namely deep geothermal energy (DGE) and shale gas (between-subject design). Three incrementally different formats of written risk communication were tested: (i) qualitative, (ii) qualitative and quantitative, and (iii) qualitative and quantitative with risk comparison. Respondents found the latter two the easiest to understand, the most exact, and liked them the most. Adding uncertainty and expert confidence statements made the risk communication less clear, less easy to understand and increased concern. Above all, the technology for which risks are communicated and its acceptance mattered strongly: respondents in the shale gas condition found the identical risk communication less trustworthy and more concerning than in the DGE conditions. They also liked the risk communication overall less. For practitioners in DGE or shale gas projects, the study shows that the public would appreciate efforts in describing LPHC risks with numbers and optionally risk comparisons. However, there seems to be a trade-off between aiming for transparency by disclosing uncertainty and limited expert confidence, and thereby decreasing clarity and increasing concern in the view of the public. © 2017 Society for Risk Analysis.

Vertigo and dizziness in adolescents: Risk factors and their population attributable risk

PubMed Central

Albers, Lucia; Straube, Andreas; Gerstl, Lucia; Blum, Bernhard; Langhagen, Thyra; Jahn, Klaus; Heinen, Florian; von Kries, Rüdiger; Landgraf, Mirjam N.

2017-01-01

Objectives To assess potential risk factors for vertigo and dizziness in adolescents and to evaluate their variability by different vertigo types. The role of possible risk factors for vertigo and dizziness in adolescents and their population relevance needs to be addressed in order to design preventive strategies. Study design The study population consisted of 1482 school-children between the age of 12 and 19 years, who were instructed to fill out a questionnaire on different vertigo types and related potential risk factors. The questionnaire specifically asked for any vertigo, spinning vertigo, swaying vertigo, orthostatic dizziness, and unspecified dizziness. Further a wide range of potential risk factors were addressed including gender, stress, muscular pain in the neck and shoulder region, sleep duration, migraine, coffee and alcohol consumption, physical activity and smoking. Results Gender, stress, muscular pain in the neck and shoulder region, sleep duration and migraine were identified as independent risk factors following mutual adjustment: The relative risk was 1.17 [1.10–1.25] for female sex, 1.07 [1.02–1.13] for stress, 1.24 [1.17–1.32] for muscular pain, and 1.09 [1.03–1.14] for migraine. The population attributable risk explained by these risk factors was 26%, with muscular pain, stress, and migraine accounting for 11%, 4%, and 3% respectively. Conclusion Several established risk factors in adults were also identified in adolescents. Risk factors amenable to prevention accounted for 17% of the total population risk. Therefore, interventions targeting these risk factors may be warranted. PMID:29131843

Living near nuclear power plants and thyroid cancer risk: A systematic review and meta-analysis.

PubMed

Kim, Jaeyoung; Bang, Yejin; Lee, Won Jin

2016-02-01

There has been public concern regarding the safety of residing near nuclear power plants, and the extent of risk for thyroid cancer among adults living near nuclear power plants has not been fully explored. In the present study, a systematic review and meta-analysis of epidemiologic studies was conducted to investigate the association between living near nuclear power plants and the risk of thyroid cancer. A comprehensive literature search was performed on studies published up to March 2015 on the association between nuclear power plants and thyroid cancer risk. The summary standardized incidence ratio (SIR), standardized mortality ratio (SMR), and 95% confidence intervals (CIs) were calculated using a random-effect model of meta-analysis. Sensitivity analyses were performed by study quality. Thirteen studies were included in the meta-analysis, covering 36 nuclear power stations in 10 countries. Overall, summary estimates showed no significant increased thyroid cancer incidence or mortality among residents living near nuclear power plants (summary SIR=0.98; 95% CI 0.87-1.11, summary SMR=0.80; 95% CI 0.62-1.04). The pooled estimates did not reveal different patterns of risk by gender, exposure definition, or reference population. However, sensitivity analysis by exposure definition showed that living less than 20 km from nuclear power plants was associated with a significant increase in the risk of thyroid cancer in well-designed studies (summary OR=1.75; 95% CI 1.17-2.64). Our study does not support an association between living near nuclear power plants and risk of thyroid cancer but does support a need for well-designed future studies. Copyright © 2015 Elsevier Ltd. All rights reserved.

Occupational health and safety: Designing and building with MACBETH a value risk-matrix for evaluating health and safety risks

NASA Astrophysics Data System (ADS)

Lopes, D. F.; Oliveira, M. D.; Costa, C. A. Bana e.

2015-05-01

Risk matrices (RMs) are commonly used to evaluate health and safety risks. Nonetheless, they violate some theoretical principles that compromise their feasibility and use. This study describes how multiple criteria decision analysis methods have been used to improve the design and the deployment of RMs to evaluate health and safety risks at the Occupational Health and Safety Unit (OHSU) of the Regional Health Administration of Lisbon and Tagus Valley. ‘Value risk-matrices’ (VRMs) are built with the MACBETH approach in four modelling steps: a) structuring risk impacts, involving the construction of descriptors of impact that link risk events with health impacts and are informed by scientific evidence; b) generating a value measurement scale of risk impacts, by applying the MACBETH-Choquet procedure; c) building a system for eliciting subjective probabilities that makes use of a numerical probability scale that was constructed with MACBETH qualitative judgments on likelihood; d) and defining a classification colouring scheme for the VRM. A VRM built with OHSU members was implemented in a decision support system which will be used by OHSU members to evaluate health and safety risks and to identify risk mitigation actions.

Ergonomics principles to design clothing work for electrical workers in Colombia.

PubMed

Castillo, Juan; Cubillos, A

2012-01-01

The recent development of the Colombian legislation, have been identified the need to develop protective clothing to work according to specifications from the work done and in compliance with international standards. These involve the development and design of new strategies and measures for work clothing design. In this study we analyzes the activities of the workers in the electrical sector, the method analyzes the risks activity data in various activities, that activities include power generation plants, local facilities, industrial facilities and maintenance of urban and rural networks. The analyses method is focused on ergonomic approach, risk analysis is done, we evaluate the role of security expert and we use a design algorithm developed for this purpose. The result of this study is the identification of constraints and variables that contribute to the development of a model of analysis that leads to the development the work protective clothes.

Design and validation of a questionnaire for measuring perceived risk of skin cancer.

PubMed

Morales-Sánchez, M A; Peralta-Pedrero, M L; Domínguez-Gómez, M A

2014-04-01

A perceived risk of cancer encourages preventive behavior while the lack of such a perception is a barrier to risk reduction. There are no instruments in Spanish to measure this perceived risk and thus quantify response to interventions for preventing this disease at a population level. The aim of this study was to design and validate a self-administered questionnaire for measuring the perceived risk of skin cancer. A self-administered questionnaire with a visual Likert-type scale was designed based on the results of the analysis of the content of a survey performed in 100 patients in the Dr. Ladislao de la Pascua Skin Clinic, Distrito Federal México, Mexico. Subsequently, the questionnaire was administered to a sample of 359 adult patients who attended the clinic for the first time. As no gold standard exists for measuring the perceived risk of skin cancer, the construct was validated through factor analysis. The final questionnaire had 18 items. The internal consistency measured with Cronbach α was 0.824 overall. In the factor analysis, 4 factors (denoted as affective, behavioral, severity, and susceptibility) and an indicator of risk accounted for 65.133% of the variance. The psychometric properties of the scale were appropriate for measuring the perception of risk in adult patients (aged 18 years or more) who attended the dermatology clinic. Copyright © 2013 Elsevier España, S.L. and AEDV. All rights reserved.

78 FR 79044 - Self-Regulatory Organizations; New York Stock Exchange LLC; Notice of Filing and Immediate...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-27

... Proposed Rule Change to Offer Risk Management Tools Designed to Allow Member Organizations to Monitor and... of the Proposed Rule Change The Exchange proposes to offer risk management tools designed to allow... risk management tools designed to allow member organizations to monitor and address exposure to risk...

Bridging the ';knowing and doing gap' in disaster risk reduction using design and design thinking; Ideation of concepts to improve hazard preparedness and response

NASA Astrophysics Data System (ADS)

van Manen, S. M.

2013-12-01

The central goal of disaster risk reduction (DRR) is to reduce the impact and cost of natural hazards, in human, environmental and economic terms. There are numerous approaches that aim to achieve this but recent studies have shown a substantial gap between risk reduction actions taken at national and local levels. The traditional media of the scientist: education, outreach and increasingly community involvement, have been shown to raise levels of awareness and understanding but generate little change in terms of people's actions. This can be attributed to the differences in hazard perception and the relative weight placed on various aspects by scientists, authorities and communities as a result of non-hazard related factors. Therefore DRR, particularly when placed in its social, environmental and economic contexts, is an excellent example of what is termed a ';wicked problem': a problem that is difficult to formulate, where data to base decisions on are incomplete, the stakeholders are many and they hold contradicting views and the consequences of actions on the wider system are unclear. Although both science and design are geared towards problem solving, design, in drawing equally on art and engineering skills, does so in a fundamentally different but complementary way. Neither design nor science will solve the wicked problem that is DRR, but scientists, engineers and designers can improve the current state of disaster risk reduction by tackling aspects of underlying risk factors. This work will present concepts aimed at engaging people in novel and innovative ways with scientific results, with a specific focus on improving hazard preparedness and tangible, rather than abstract, ways of communicating hazard levels. Key considerations include the need to graft onto existing behaviours or innovate on existing products to simplify implementation, the possibility to co-create and connect through design and balancing desirability with technical and economical feasibility. The examples presented are intended to initiate and illustrate discussion regarding the role design and design thinking can play in disaster risk reduction.

“We as Drug Addicts Need that Program”: Insight from Rural African American Cocaine Users on Designing a Sexual Risk Reduction Intervention for Their Community

PubMed Central

Montgomery, Brooke E. E.; Stewart, Katharine E.; Wright, Patricia B.; McSweeney, Jean; Booth, Brenda M.

2013-01-01

This focused ethnographic study examines data collected in 2007 from four gender- and age-specific focus groups (FGs) (N = 31) to inform the development of a sexual risk reduction intervention for African American cocaine users in rural Arkansas. A semi-structured protocol was used to guide audio-recorded FGs. Data were entered into Ethnograph and analyzed using constant comparison and content analysis. Four codes with accompanying factors emerged from the data and revealed recommendations for sexual risk reduction interventions with similar populations. Intervention design implications and challenges, study limitations, and future research are discussed. The study was supported by funds from the National Institute of Nursing Research (P20 NR009006-01) and the National Institute on Drug Abuse (1R01DA024575-01 and F31 DA026286-01). PMID:22216991

The South Asian heart lifestyle intervention (SAHELI) study to improve cardiovascular risk factors in a community setting: Design and methods

PubMed Central

Kandula, Namratha R.; Patel, Yasin; Dave, Swapna; Seguil, Paola; Kumar, Santosh; Baker, David W.; Spring, Bonnie; Siddique, Juned

2013-01-01

Disseminating and implementing evidence-based, cardiovascular disease (CVD) prevention lifestyle interventions in community settings and in ethnic minority populations is a challenge. We describe the design and methods for the South Asian heart lifestyle intervention (SAHELI) study, a pilot study designed to determine the feasibility and initial efficacy of a culturally-targeted, community-based lifestyle intervention to improve physical activity and diet behaviors among medically underserved South Asians (SAs). Participants with at least one CVD risk factor will be randomized to either a lifestyle intervention or a control group. Participants in both groups will be screened in a community setting and receive a primary care referral after randomization. Intervention participants will receive 6 weeks of group classes, followed by 12 weeks of individual telephone support where they will be encouraged to initiate and maintain a healthy lifestyle goal. Control participants will receive their screening results and monthly mailings on CVD prevention. Primary outcomes will be changes in moderate/vigorous physical activity and saturated fat intake between baseline, 3-, and 6-month follow-up. Secondary outcomes will be changes in weight, clinical risk factors, primary care visits, self-efficacy, and social support. This study will be one of the first to pilot-test a lifestyle intervention for SAs, one of the fastest growing racial/ethnic groups in the U.S. and one with disparate CVD risk. Results of this pilot study will provide preliminary data about the efficacy of a lifestyle intervention on CVD risk in SAs and inform community-engaged CVD prevention efforts in an increasingly diverse U.S. population. PMID:24060673

Finnish Prenatal Study of Autism and Autism Spectrum Disorders (FIPS-A): Overview and Design

ERIC Educational Resources Information Center

Lampi, Katja M.; Banerjee, P. Nina; Gissler, Mika; Hinkka-Yli-Salomaki, Susanna; Huttunen, Jukka; Kulmala, Ulla; Lindroos, Jarna; Niemela, Solja; Rihko, Maria; Ristkari, Terja; Saanakorpi, Kristiina; Sarlin, Tanja; Sillanmaki, Lauri; McKeague, Ian W.; Surcel, Helja-Marja; Helenius, Hans; Brown, Alan S.; Sourander, Andre

2011-01-01

This article presents an overview of the Finnish Prenatal Study of Autism and Autism Spectrum Disorders (FIPS-A), a new study designed to examine the relationship between prenatal serologic factors, mediating and moderating developmental antecedents, and risk of autism spectrum disorders (ASD). The FIPS-A is based on register linkages between…

A Systematic Review of the Effects of Behavioral Counseling on Sexual Risk Behaviors and HIV/STI Prevalence in Low- and Middle-Income Countries.

PubMed

Zajac, Kristyn; Kennedy, Caitlin E; Fonner, Virginia A; Armstrong, Kevin S; O'Reilly, Kevin R; Sweat, Michael D

2015-07-01

The purpose of this study was to assess the effectiveness of behavioral counseling interventions in reducing sexual risk behaviors and HIV/STI prevalence in low- and middle-income countries. A systematic review of papers published between 1990 and 2011 was conducted, identifying studies that utilized either a multi-arm or pre-post design and presented post-intervention data. Standardized methods of searching and data abstraction were used, and 30 studies met inclusion criteria. Results are summarized by intervention groups: (a) people living with HIV; (b) people who use drugs and alcohol; (c) serodiscordant couples; (d) key populations for HIV prevention; and (e) people at low to moderate HIV risk. Evidence for the effectiveness of behavioral counseling was mixed, with more rigorously designed studies often showing modest or no effects. Recommendations about the use of behavioral counseling in developing countries are made based on study results and in light of the field's movement towards combination prevention programs.

Hypertension-misattributed kidney disease in African Americans.

PubMed

Skorecki, Karl L; Wasser, Walter G

2013-01-01

Lipkowitz et al. extend the African American Study of Kidney Disease and Hypertension to the level of genetic epidemiology, in a case-control study design. Analysis of genotypes at the APOL1 kidney disease risk region supports a paradigm shift in which genetic risk is proximate to both kidney disease and hypertension. The findings mandate urgency in clarifying mechanisms whereby APOL1 region risk variants interact with environmental triggers to cause progressive kidney disease accompanied by dangerous hypertension.

Practicalities of Using a Modified Version of the Cochrane Collaboration Risk of Bias Tool for Randomised and Non-Randomised Study Designs Applied in a Health Technology Assessment Setting

ERIC Educational Resources Information Center

Robertson, Clare; Ramsay, Craig; Gurung, Tara; Mowatt, Graham; Pickard, Robert; Sharma, Pawana

2014-01-01

We describe our experience of using a modified version of the Cochrane risk of bias (RoB) tool for randomised and non-randomised comparative studies. Objectives: (1) To assess time to complete RoB assessment; (2) To assess inter-rater agreement; and (3) To explore the association between RoB and treatment effect size. Methods: Cochrane risk of…

Testing the Developmental Origins of Health and Disease Hypothesis for Psychopathology Using Family-Based Quasi-Experimental Designs

PubMed Central

D’Onofrio, Brian M.; Class, Quetzal A.; Lahey, Benjamin B.; Larsson, Henrik

2014-01-01

The Developmental Origin of Health and Disease (DOHaD) hypothesis is a broad theoretical framework that emphasizes how early risk factors have a causal influence on psychopathology. Researchers have raised concerns about the causal interpretation of statistical associations between early risk factors and later psychopathology because most existing studies have been unable to rule out the possibility of environmental and genetic confounding. In this paper we illustrate how family-based quasi-experimental designs can test the DOHaD hypothesis by ruling out alternative hypotheses. We review the logic underlying sibling-comparison, co-twin control, offspring of siblings/twins, adoption, and in vitro fertilization designs. We then present results from studies using these designs focused on broad indices of fetal development (low birth weight and gestational age) and a particular teratogen, smoking during pregnancy. The results provide mixed support for the DOHaD hypothesis for psychopathology, illustrating the critical need to use design features that rule out unmeasured confounding. PMID:25364377

Rationale and Design of the Vitamin D and Type 2 Diabetes (D2d) Study: A Diabetes Prevention Trial

PubMed Central

Pittas, Anastassios G.; Dawson-Hughes, Bess; Rosen, Clifford J.; Ware, James H.; Knowler, William C.; Staten, Myrlene A.

2014-01-01

OBJECTIVE Observational studies suggest that vitamin D may lower the risk of type 2 diabetes. However, data from long-term trials are lacking. The Vitamin D and Type 2 Diabetes (D2d) study is a randomized clinical trial designed to examine whether a causal relationship exists between vitamin D supplementation and the development of diabetes in people at high risk for type 2 diabetes. RESEARCH DESIGN AND METHODS D2d was designed with support from a U34 planning grant from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The final protocol was approved by the D2d Research Group, the data and safety monitoring board, and NIDDK. Key eligibility criteria are age ≥30 years, BMI of 24 (22.5 for Asian Americans) to 42 kg/m2, increased risk for diabetes (defined as meeting two of three glycemic criteria for prediabetes established by the American Diabetes Association [fasting glucose 100–125 mg/dL (5.5–6.9 mmol/L), 2-h postload glucose after 75-g glucose load 140–199 mg/dL (7.7–11.0 mmol/L), hemoglobin A1c 5.7–6.4% (39–46 mmol/mol)]), and no hyperparathyroidism, nephrolithiasis, or hypercalcemia. D2d participants are randomized to once-daily vitamin D3 (cholecalciferol 4,000 IU) or placebo and followed for an average of 3 years. The primary end point is time to incident diabetes as assessed by laboratory criteria during the study or by adjudication if diagnosed outside of D2d. Recruitment was initiated at the end of 2013. CONCLUSIONS D2d will test whether vitamin D supplementation is safe and effective at lowering the risk of progression to diabetes in people at high risk for type 2 diabetes. PMID:25205139

The comparison of various approach to evaluation erosion risks and design control erosion measures

NASA Astrophysics Data System (ADS)

Kapicka, Jiri

2015-04-01

In the present is in the Czech Republic one methodology how to compute and compare erosion risks. This methodology contain also method to design erosion control measures. The base of this methodology is Universal Soil Loss Equation (USLE) and their result long-term average annual rate of erosion (G). This methodology is used for landscape planners. Data and statistics from database of erosion events in the Czech Republic shows that many troubles and damages are from local episodes of erosion events. An extent of these events and theirs impact are conditional to local precipitation events, current plant phase and soil conditions. These erosion events can do troubles and damages on agriculture land, municipally property and hydro components and even in a location is from point of view long-term average annual rate of erosion in good conditions. Other way how to compute and compare erosion risks is episodes approach. In this paper is presented the compare of various approach to compute erosion risks. The comparison was computed to locality from database of erosion events on agricultural land in the Czech Republic where have been records two erosion events. The study area is a simple agriculture land without any barriers that can have high influence to water flow and soil sediment transport. The computation of erosion risks (for all methodology) was based on laboratory analysis of soil samples which was sampled on study area. Results of the methodology USLE, MUSLE and results from mathematical model Erosion 3D have been compared. Variances of the results in space distribution of the places with highest soil erosion where compared and discussed. Other part presents variances of design control erosion measures where their design was done on based different methodology. The results shows variance of computed erosion risks which was done by different methodology. These variances can start discussion about different approach how compute and evaluate erosion risks in areas with different importance.

Rationale, objectives, and design of the EUTrigTreat clinical study: a prospective observational study for arrhythmia risk stratification and assessment of interrelationships among repolarization markers and genotype

PubMed Central

Seegers, Joachim; Vos, Marc A.; Flevari, Panagiota; Willems, Rik; Sohns, Christian; Vollmann, Dirk; Lüthje, Lars; Kremastinos, Dimitrios T.; Floré, Vincent; Meine, Mathias; Tuinenburg, Anton; Myles, Rachel C.; Simon, Dirk; Brockmöller, Jürgen; Friede, Tim; Hasenfuß, Gerd; Lehnart, Stephan E.; Zabel, Markus

2012-01-01

Aims The EUTrigTreat clinical study has been designed as a prospective multicentre observational study and aims to (i) risk stratify patients with an implantable cardioverter defibrillator (ICD) for mortality and shock risk using multiple novel and established risk markers, (ii) explore a link between repolarization biomarkers and genetics of ion (Ca2+, Na+, K+) metabolism, (iii) compare the results of invasive and non-invasive electrophysiological (EP) testing, (iv) assess changes of non-invasive risk stratification tests over time, and (v) associate arrythmogenomic risk through 19 candidate genes. Methods and results Patients with clinical ICD indication are eligible for the trial. Upon inclusion, patients will undergo non-invasive risk stratification, including beat-to-beat variability of repolarization (BVR), T-wave alternans, T-wave morphology variables, ambient arrhythmias from Holter, heart rate variability, and heart rate turbulence. Non-invasive or invasive programmed electrical stimulation will assess inducibility of ventricular arrhythmias, with the latter including recordings of monophasic action potentials and assessment of restitution properties. Established candidate genes are screened for variants. The primary endpoint is all-cause mortality, while one of the secondary endpoints is ICD shock risk. A mean follow-up of 3.3 years is anticipated. Non-invasive testing will be repeated annually during follow-up. It has been calculated that 700 patients are required to identify risk predictors of the primary endpoint, with a possible increase to 1000 patients based on interim risk analysis. Conclusion The EUTrigTreat clinical study aims to overcome current shortcomings in sudden cardiac death risk stratification and to answer several related research questions. The initial patient recruitment is expected to be completed in July 2012, and follow-up is expected to end in September 2014. Clinicaltrials.gov identifier: NCT01209494. PMID:22117037

The Effect of a "Learner as Multimedia Designer" Environment on At-Risk High School Students' Motivation and Learning of Design Knowledge.

ERIC Educational Resources Information Center

Liu, Min; Rutledge, Keith

This paper investigates the effect of engaging students in designing interactive multimedia programs. The design process has been shown to heighten motivation and to develop skills in project management, research, organization and representation, presentation, and reflection. At the same time, previous studies have also revealed that it is…

Resilience Theory: Risk and Protective Factors for Novice Special Education Teachers

ERIC Educational Resources Information Center

Benjamin, Thomas L.; Black, Rhonda S.

2012-01-01

This study describes experiences of novice special education teachers in rural areas in Hawaii through a lens of resiliency theory. Two types of support--administrative and collegial--were examined in terms of being risk or protective processes. A case study design was used to give voice to five participants who expressed their satisfaction and…

Point process methods in epidemiology: application to the analysis of human immunodeficiency virus/acquired immunodeficiency syndrome mortality in urban areas.

PubMed

Quesada, Jose Antonio; Melchor, Inmaculada; Nolasco, Andreu

2017-05-26

The analysis of spatio-temporal patterns of disease or death in urban areas has been developed mainly from the ecological studies approach. These designs may have some limitations like the ecological fallacy and instability with few cases. The objective of this study was to apply the point process methodology, as a complement to that of aggregated data, to study HIV/AIDS mortality in men in the city of Alicante (Spain). A case-control study in residents in the city during the period 2004-2011 was designed. Cases were men who died from HIV/AIDS and controls represented the general population, matched by age to cases. The risk surfaces of death over the city were estimated using the log-risk function of intensities, and we contrasted their temporal variations over the two periods. High risk significant areas of death by HIV/AIDS, which coincide with the most deprived areas in the city, were detected. Significant spatial change of the areas at risk between the periods studied was not detected. The point process methodology is a useful tool to analyse the patterns of death by HIV/AIDS in urban areas.

Meta-Analysis of the Association between Tea Intake and the Risk of Cognitive Disorders

PubMed Central

Ma, Qing-Ping; Huang, Chen; Cui, Qiao-Yun; Yang, Ding-Jun; Sun, Kang; Chen, Xuan; Li, Xing-Hui

2016-01-01

Background Alzheimer’s disease is a common neurodegenerative disorder in elderly. This study was aimed to systematically evaluate the association between tea intake and the risk of cognitive disorders by meta-analysis. Methods and Findings PubMed, Embase and Wanfang databases were systematically searched and a total of 26 observational studies were included in this study. Odds ratios (ORs) and the corresponding 95% confidence intervals (CIs) were calculated and pooled by using fixed or random effects models according to the degree of heterogeneity. Results The overall pooled analysis indicated that tea intake could significantly reduce the risk of cognitive disorders (OR = 0.65, 95%CI = 0.58–0.73). Subgroup analyses were conducted based on study design, population, frequency of tea drinking and type of cognitive disorders. The results showed that tea drinking was significantly associated with the reduced incidence of cognitive disorders in all of subgroups based on study design and frequency of tea drinking. In particular, tea drinking was inversely associated with the risk of cognitive impairment (CoI), mild cognitive impairment (MCI), cognitive decline and ungrouped cognitive disorders. Moreover, for population subgroups, the significant association was only found in Chinese people. Conclusion Our study suggests that daily tea drinking is associated with decreased risk of CoI, MCI and cognitive decline in the elderly. However, the association between tea intake and Alzheimer’s disease remains elusive. PMID:27824892

The effect of high-efficiency particulate air respirator design on occupational health: a pilot study balancing risks in the real world.

PubMed

Eck, E K; Vannier, A

1997-02-01

To quantify specific factors believed to increase healthcare worker (HCW) risk for contaminated sharps injuries (eg, visibility, communication, and range of motion); to quantify the degree to which respirators of various designs impacted those same factors; and to assess HCW opinions about the suitability of selected respirators with respect to patient care and user compliance criteria. Sharps injury data from seven hospitals were analyzed to determine the potential contribution of visibility, communication, and range of motion to reported injuries. Healthcare workers representing various clinical specialties and physical characteristics were examined at baseline and while wearing five different respirators to quantify the impact of respirator design on visibility, communication, and range of motion. Healthcare workers were interviewed and completed a survey assessing each respirator. Hospital and ambulatory-care settings. Population-based and convenience sample. Communication, visibility, and range of motion were found to affect contaminated sharps injuries significantly. Selected high-efficiency particulate air (HEPA) respirators were found to have a negative impact on each of these variables. Healthcare workers involved in the study also reported compliance criteria problems with selected HEPA respirators, which may effect implementation of respiratory precautions adversely. Current HEPA respirators, because of their design, potentially increase the risk of bloodborne pathogen exposure through sharps injuries. We conclude that mandating respirators without regard to the potential impact of their design to the sharps injuries may be counterproductive to HCW safety, because they may increase, rather than decrease, overall occupational risk to HCWs.

Risk assessment and experimental design in the development of a prolonged release drug delivery system with paliperidone

PubMed Central

Iurian, Sonia; Turdean, Luana; Tomuta, Ioan

2017-01-01

This study focuses on the development of a drug product based on a risk assessment-based approach, within the quality by design paradigm. A prolonged release system was proposed for paliperidone (Pal) delivery, containing Kollidon® SR as an insoluble matrix agent and hydroxypropyl cellulose, hydroxypropyl methylcellulose (HPMC), or sodium carboxymethyl cellulose as a hydrophilic polymer. The experimental part was preceded by the identification of potential sources of variability through Ishikawa diagrams, and failure mode and effects analysis was used to deliver the critical process parameters that were further optimized by design of experiments. A D-optimal design was used to investigate the effects of Kollidon SR ratio (X1), the type of hydrophilic polymer (X2), and the percentage of hydrophilic polymer (X3) on the percentages of dissolved Pal over 24 h (Y1–Y9). Effects expressed as regression coefficients and response surfaces were generated, along with a design space for the preparation of a target formulation in an experimental area with low error risk. The optimal formulation contained 27.62% Kollidon SR and 8.73% HPMC and achieved the prolonged release of Pal, with low burst effect, at ratios that were very close to the ones predicted by the model. Thus, the parameters with the highest impact on the final product quality were studied, and safe ranges were established for their variations. Finally, a risk mitigation and control strategy was proposed to assure the quality of the system, by constant process monitoring. PMID:28331293

Introducing a Transdisciplinary Approach in Studies regarding Risk Assessment and Management in Educational Programs for Environmental Engineers and Planners

ERIC Educational Resources Information Center

Menoni, Scira

2006-01-01

Purpose: The purpose of this paper is to discuss how long term risk prevention and civil protection may enter in university programs for environmental engineers and urban and regional planners. Design/methodology/approach: First the distinction between long term risk prevention and emergency preparedness is made, showing that while the first has…

How Much Is that Exam Grade Really Worth? An Estimation of Student Risk Aversion to Their Unknown Final College Course Grades

ERIC Educational Resources Information Center

Nalley, Lanier; McKenzie, Andrew

2011-01-01

This study created an experimental design with which students can empirically assess their risk behavior with respect to exam grades within an expected utility framework. Specifically, the authors analyzed students' risk preferences associated with taking exams and earning a "risky" unknown grade versus not taking exams and instead…

Contextual Risk and Parenting as Predictors of Effortful Control and Social Competence in Preschool Children

ERIC Educational Resources Information Center

Lengua, Liliana J.; Honorado, Elizabeth; Bush, Nicole R.

2007-01-01

Using a short-term longitudinal design (6 months), this study examined cumulative contextual risk as a predictor of effortful control (EC) and social competence in a community sample of children (N = 80, ages 33-40 months at time 1). Maternal parenting was examined as a mediator of contextual risk. EC was assessed using laboratory tasks, and…

Design features of graphs in health risk communication: a systematic review.

PubMed

Ancker, Jessica S; Senathirajah, Yalini; Kukafka, Rita; Starren, Justin B

2006-01-01

This review describes recent experimental and focus group research on graphics as a method of communication about quantitative health risks. Some of the studies discussed in this review assessed effect of graphs on quantitative reasoning, others assessed effects on behavior or behavioral intentions, and still others assessed viewers' likes and dislikes. Graphical features that improve the accuracy of quantitative reasoning appear to differ from the features most likely to alter behavior or intentions. For example, graphs that make part-to-whole relationships available visually may help people attend to the relationship between the numerator (the number of people affected by a hazard) and the denominator (the entire population at risk), whereas graphs that show only the numerator appear to inflate the perceived risk and may induce risk-averse behavior. Viewers often preferred design features such as visual simplicity and familiarity that were not associated with accurate quantitative judgments. Communicators should not assume that all graphics are more intuitive than text; many of the studies found that patients' interpretations of the graphics were dependent upon expertise or instruction. Potentially useful directions for continuing research include interactions with educational level and numeracy and successful ways to communicate uncertainty about risk.

Reducing safety risk among underserved caregivers with an Alzheimer's home safety program.

PubMed

Levy-Storms, Lené; Cherry, Debra L; Lee, Linda J; Wolf, Sheldon M

2017-09-01

Older adults living with Alzheimer's disease (AD) experience more of the types of accidents and injuries prevalent among older adults. Relatively few studies specifically on safety risks have included older adults of color and tested interventions. This pilot study tested the feasibility and evaluability of educating Hispanic and African American caregivers of patients living with AD about reducing safety risks in their homes. This outpatient memory clinic-based intervention study included a pre-/post-test survey design with two nonequivalent groups and predominately serves Hispanic and African Americans. Of 60 eligible caregivers, 67% participated in a tailored, safety training class with an optional follow-up call. The results indicate a reduction in some safety risks compared to baseline and/or a no intervention group, respectively, including leaving patients at home alone part-time (p < .01 and p < .01), getting lost (p < .05 and p < .05), going outdoors alone less often (p < .05 and p < .01), and giving themselves medicine (p < .05 and p < .01). At post-test, 47 clinically significant instances occurred, in which caregivers who participated in the intervention self-reported patients living with AD to be 'completely safe' in one or more of the safety risk items compared to 8 instances among those who did not. This pilot pre/post design with non-equivalent groups study needs refinement in a future randomized control trial. Despite limitations, this pilot study demonstrates the first feasible and evaluable intervention with both statistically and clinically significant results that suggest potential for reducing safety risks among at-risk minority patients living with AD in future research.

Development and preliminary validation of an index for indicating the risks of the design of working hours to health and wellbeing.

PubMed

Schomann, Carsten; Giebel, Ole; Nachreiner, Friedhelm

2006-01-01

BASS 4, a computer program for the design and evaluation of workings hours, is an example of an ergonomics-based software tool that can be used by safety practitioners at the shop floor with regard to legal, ergonomic, and economic criteria. Based on experiences with this computer program, a less sophisticated Working-Hours-Risk Index for assessing the quality of work schedules (including flexible work hours) to indicate risks to health and wellbeing has been developed to provide a quick and easy applicable tool for legally required risk assessments. The results of a validation study show that this risk index seems to be a promising indicator for predicting risks of health complaints and wellbeing. The purpose of the Risk Index is to simplify the evaluation process at the shop floor and provide some more general information about the quality of a work schedule that can be used for triggering preventive interventions. Such a risk index complies with practitioners' expectations and requests for easy, useful, and valid instruments.

An Intervention for HPV Risk Reduction Based on the Theory of Planned Behavior: An Exploratory Study with College-Aged Women

ERIC Educational Resources Information Center

Sweeney, Jocelyn Brineman; McAnulty, Richard D.; Reeve, Charlie; Cann, Arnie

2015-01-01

The goal of the study was to examine the effectiveness of a group intervention in reducing risks of contracting human papillomavirus (HPV) among college-aged women. Using a randomized design, the study examined the effectiveness of an HPV educational group intervention guided by the Theory of Planned Behavior. The intervention was provided in a…

The Learning and Competency Development of Master Teachers in Alternative High Schools for At-Risk Youth: A Case Study

ERIC Educational Resources Information Center

Williams, Nida W.

2012-01-01

This qualitative case study was designed to explore how master teachers in transfer high schools learn the competencies they perceive are required to engage at-risk students so that they persist and graduate. The study is based on the following assumptions: (1) The requisite teacher competencies can be defined and identified and, in fact,…

Systems Engineering Using Heritage Spacecraft Technology: Lessons Learned from Discovery and New Frontiers Deep Space Missions

NASA Technical Reports Server (NTRS)

Barley, Bryan; Newhouse, Marilyn; Clardy, Dennon

2011-01-01

In the design and development of complex spacecraft missions, project teams frequently assume the use of advanced technology or heritage systems to enable a mission or reduce the overall mission risk and cost. As projects proceed through the development life cycle, increasingly detailed knowledge of the advanced or heritage systems and the system environment identifies unanticipated issues that result in cost overruns or schedule impacts. The Discovery & New Frontiers (D&NF) Program Office recently studied cost overruns and schedule delays resulting from advanced technology or heritage assumptions for 6 D&NF missions. The goal was to identify the underlying causes for the overruns and delays, and to develop practical mitigations to assist the D&NF projects in identifying potential risks and controlling the associated impacts to proposed mission costs and schedules. The study found that the cost and schedule growth did not result from technical hurdles requiring significant technology development. Instead, systems engineering processes did not identify critical issues early enough in the design cycle to ensure project schedules and estimated costs address the inherent risks. In general, the overruns were traceable to: inadequate understanding of the heritage system s behavior within the proposed spacecraft design and mission environment; an insufficient level of experience with the heritage system; or an inadequate scoping of the system-wide impacts necessary to implement the heritage or advanced technology. This presentation summarizes the study s findings and offers suggestions for improving the project s ability to identify and manage the risks inherent in the technology and heritage design solution.

Risk of Liver Injury Associated with Chinese Herbal Products Containing Radix bupleuri in 639,779 Patients with Hepatitis B Virus Infection

PubMed Central

Lee, Chang-Hsing; Wang, Jung-Der; Chen, Pau-Chung

2011-01-01

Background Chinese herbal products (CHPs) containing Radix bupleuri are often prescribed for chronic hepatitis. There have been no epidemiological studies in populations with hepatitis B virus (HBV) infection. Our study was conducted to determine the association between the use of CHPs containing Radix bupleuri and the risk of hospitalisation related to liver injury among HBV-infected patients in Taiwan. Methods From a total of 639,779 patients with diagnoses related to HBV infection, we included hospitalised adult cases with a primary diagnosis of liver injury in the database of Taiwan's national health insurance during the period 1997–2004. Case-control and case-crossover designs were used to assess the risk of hospitalisation with conditional logistic regression models constructed and adjusted for 270 conventionally hepatotoxic drugs. Cumulative doses of these CHPs and Radix bupleuri were assessed for any dose-response relationship. Findings In total, we collected 1,080 cases fulfilled the inclusion criteria. In the case-control design, the adjusted odds ratio was 1.90 (95% confidence interval [CI]: 1.30 to 2.77). The risks from prescribing the CHPs Xiao-Chai-Hu-Tang and Long-Dan-Xie-Gan-Tang were significantly high, and dose-response relationships were found. The risk of adding each 19 gm dose of Radix bupleuri was 2.19 (95% CI: 1.66 to 2.89). The results using the case-crossover design remained similar. Conclusions Prescribing Xiao-Chai-Hu-Tang, Long-Dan-Xie-Gan-Tang, or CHPs containing more than 19 gram of Radix bupleuri in HBV-infected patients might increase their risks of liver injury. Further studies are indicated to corroborate the above findings. PMID:21264326

An Introduction to Risk with a Focus on Design Diversity in the Stockpile

DOE Office of Scientific and Technical Information (OSTI.GOV)

Noone, Bailey C

2012-08-13

The maintenance and security of nuclear weapons in the stockpile involves decisions based on risk analysis and quantitative measures of risk. Risk is a factor in all decisions, a particularly important factor in decisions of a large scale. One example of high-risk decisions we will discuss is the risk involved in design diversity within the stockpile of nuclear weapons arsenal. Risk is defined as 'possibility of loss or injury' and the 'degree of probability of such loss' (Kaplan and Garrick 12). To introduce the risk involved with maintaining the weapons stockpile we will draw a parallel to the design andmore » maintenance of Southwest Airlines fleet of Boeing 737 planes. The clear benefits for cost savings in maintenance of having a uniform fleet are what historically drove Southwest to have only Boeing 737s in their fleet. Less money and resources are need for maintenance, training, and materials. Naturally, risk accompanies those benefits. A defect in a part of the plane indicates a potential defect in that same part in all the planes of the fleet. As a result, safety, business, and credibility are at risk. How much variety or diversity does the fleet need to mitigate that risk? With that question in mind, a balance is needed to accommodate the different risks and benefits of the situation. In a similar way, risk is analyzed for the design and maintenance of nuclear weapons in the stockpile. In conclusion, risk must be as low as possible when it comes to the nuclear weapons stockpile. Design and care to keep the stockpile healthy involves all aspects of risk management. Design diversity is a method that helps to mitigate risk, and to help balance options in stockpile stewardship.« less

Travel health risk perceptions and prevention behaviors of US study abroad students.

PubMed

Hartjes, Laurie B; Baumann, Linda C; Henriques, Jeffrey B

2009-01-01

The number of American study abroad students increased more than 150% in the past decade, along with growth in destinations with increased health risks. This study investigated travel health risk perceptions and prevention behaviors to guide interventions that address the emerging health needs of US study abroad students. A cross-sectional design was used to collect data from 318 American study abroad students using a Web-based survey. The primary source of travel health information was youth-oriented travel guidebooks (85%). The grand mean risk perception score for 18 travel health threats was 1.7 on a 1 to 4 scale, with top-rated threats being contaminated food/water, psychological distress, personal assault, and excessive sun exposure. Predeparture advice was received from primary care providers (52%) and travel health specialists (18%). Additional prevention measures were vaccines (42%) and medication (24%). Of 114 students listing their travel vaccinations, 11% described receiving a malaria vaccine and 4% a hepatitis C vaccine, although no such vaccines exist. Most respondents were confident/very confident in their ability to engage in prevention behaviors (94%). Health problems were primarily infectious disease (70%), psychological distress (10%), and injuries (8%). When asked if prior travel destinations involved areas where malaria transmission occurs, 20% responded, "Don't know." Identified gaps in travel health knowledge and prevention behaviors may produce hazardous consequences when combined with low-perceived risk, reliance on travel guidebooks for health information, and high ratings for prevention self-efficacy. Future research is needed to test the effectiveness of educational interventions designed for student travelers who would benefit from guided practice with destination-specific risk appraisal and prevention planning. Web-based educational resources are a good fit for this population because they are easily updated, available in all phases of travel, and can accommodate interactive multimedia designs that actively engage and motivate students to adopt prevention behaviors.

Are green building features safe for preventive maintenance workers? Examining the evidence.

PubMed

Omar, Mohamed Shamun; Quinn, Margaret M; Buchholz, Bryan; Geiser, Ken

2013-04-01

Many newly constructed green buildings (GB) are certified using the United States Green Building Council (USGBC) Leadership in Energy and Environmental Design (LEED) rating system for new construction and major renovation which focuses on architectural and mechanical design to conserve energy, reduce environmental harm, and enhance indoor quality for occupants. This study evaluated the preventive maintenance (PM) worker occupational safety and health (OSH) risks related to the design of GB. PM job hazard analyses (JHA) were performed on the tasks required to operate and maintain five GB features selected from 13 LEED certified GB. A 22-item JHA and OSH risk scoring system were developed. Potentially serious OSH hazards included: green roofs made of slippery material without fall protection; energy recovery wheels and storm water harvesting systems in confined spaces; skylights without guard rails; and tight geothermal well mechanical rooms constraining safe preventive practices. GB can present PM OSH risks and these should be eliminated in the building design phase. Copyright © 2013 Wiley Periodicals, Inc.

Design definition study of NASA/Navy lift/cruise fan V/STOL aircraft

NASA Technical Reports Server (NTRS)

1975-01-01

Assessed are the risks associated with the lift/cruise fan technology V/STOL aircraft program. Three candidate concepts for the technology aircraft design approach are considered: the lowspeed only modification, the full performance modification, and the all new aircraft concepts. Survey results indicate that the lift/cruise fan technology aircraft program is feasible, from the standpoint of technical risk, with some evidence of uncertainty of meeting the planned schedule and relatively minor impact on estimated program costs.

Hazard identification and risk assessment for biologics targeting the immune system.

PubMed

Weir, Andrea B

2008-01-01

Biologic pharmaceuticals include a variety of products, such as monoclonal antibodies, fusion proteins and cytokines. Products in those classes include immunomodulatory biologics, which are intended to enhance or diminish the activity of the immune system. Immunomodulatory biologics have been approved by the U.S. FDA for a variety of indications, including cancer and inflammatory conditions. Prior to gaining approval for marketing, sponsoring companies for all types of products must demonstrate a product's safety in toxicology studies conducted in animals and show safety and efficacy in clinical trials conducted in patients. The overall goal of toxicology studies, which applies to immunomodulatory and other product types, is to identify the hazards that products pose to humans. Because biologics are generally highly selective for specific targets (receptors/epitopes), conducting toxicology studies in animal models with the target is essential. Such animals are referred to as pharmacologically relevant. Endpoints routinely included in toxicology studies, such as hematology, organ weight and histopathology, can be used to assess the effect of a product on the structure of the immune system. Additionally, specialized endpoints, such as immunophenotyping and immune function tests, can be used to define effects of immunomodulatory products on the immune system. Following hazard identification, risks posed to patients are assessed and managed. Risks can be managed through clinical trial design and risk communication, a practice that applies to immunomodulatory and other product types. Examples of risk management in clinical trial design include establishing a safe starting dose, defining the appropriate patient population and establishing appropriate patient monitoring. Risk communication starts during clinical trials and continues after product approval. A combination of hazard identification, risk assessment and risk management allows for drug development to proceed with minimum risks to patients.

CARING (CAncer Risk and INsulin analoGues): the association of diabetes mellitus and cancer risk with focus on possible determinants - a systematic review and a meta-analysis.

PubMed

Starup-Linde, Jakob; Karlstad, Oystein; Eriksen, Stine Aistrup; Vestergaard, Peter; Bronsveld, Heleen K; de Vries, Frank; Andersen, Morten; Auvinen, Anssi; Haukka, Jari; Hjellvik, Vidar; Bazelier, Marloes T; Boer, Anthonius de; Furu, Kari; De Bruin, Marie L

2013-11-01

Patients suffering from diabetes mellitus (DM) may experience an increased risk of cancer; however, it is not certain whether this effect is due to diabetes per se. To examine the association between DM and cancers by a systematic review and meta-analysis according to the PRISMA guidelines. The systematic literature search includes Medline at PubMed, Embase, Cinahl, Bibliotek.dk, Cochrane library, Web of Science and SveMed+ with the search terms: "Diabetes mellitus", "Neoplasms", and "Risk of cancer". The included studies compared the risk of cancer in diabetic patients versus non-diabetic patients. All types of observational study designs were included. Diabetes patients were at a substantially increased risk of liver (RR=2.1), and pancreas (RR=2.2) cancer. Modestly elevated significant risks were also found for ovary (RR=1.2), breast (RR=1.1), cervix (RR=1.3), endometrial (RR=1.4), several digestive tract (RR=1.1-1.5), kidney (RR=1.4), and bladder cancer (RR=1.1). The findings were similar for men and women, and unrelated to study design. Meta-regression analyses showed limited effect modification of body mass index, and possible effect modification of age, gender, with some influence of study characteristics (population source, cancer- and diabetes ascertainment). Publication bias seemed to be present. Only published data were used in the analyses. The systematic review and meta-analysis confirm the previous results of increased cancer risk in diabetes and extend this to additional cancer sites. Physicians in contact with patients with diabetes should be aware that diabetes patients are at an increased risk of cancer.

Infant siblings and the investigation of autism risk factors

PubMed Central

2012-01-01

Infant sibling studies have been at the vanguard of autism spectrum disorders (ASD) research over the past decade, providing important new knowledge about the earliest emerging signs of ASD and expanding our understanding of the developmental course of this complex disorder. Studies focused on siblings of children with ASD also have unrealized potential for contributing to ASD etiologic research. Moving targeted time of enrollment back from infancy toward conception creates tremendous opportunities for optimally studying risk factors and risk biomarkers during the pre-, peri- and neonatal periods. By doing so, a traditional sibling study, which already incorporates close developmental follow-up of at-risk infants through the third year of life, is essentially reconfigured as an enriched-risk pregnancy cohort study. This review considers the enriched-risk pregnancy cohort approach of studying infant siblings in the context of current thinking on ASD etiologic mechanisms. It then discusses the key features of this approach and provides a description of the design and implementation strategy of one major ASD enriched-risk pregnancy cohort study: the Early Autism Risk Longitudinal Investigation (EARLI). PMID:22958474

78 FR 5462 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-25

... these decisionmaking processes will be applied by FDA to help design effective communication strategies..., beliefs, and behaviors--and use risk communications; (2) more efficiently and effectively design messages... provided about the design and methodology of the pretests and the studies to effectively comment on the...

Interactive graphics to demonstrate health risks: formative development and qualitative evaluation

PubMed Central

Ancker, Jessica S.; Chan, Connie; Kukafka, Rita

2015-01-01

Background Recent findings suggest that interactive game-like graphics might be useful in communicating probabilities. We developed a prototype for a risk communication module, focusing on eliciting users’ preferences for different interactive graphics and assessing usability and user interpretations. Methods Focus groups and iterative design methods. Results Feedback from five focus groups was used to design the graphics. The final version displayed a matrix of square buttons; clicking on any button allowed the user to see whether the stick figure underneath was affected by the health outcome. When participants used this interaction to learn about a risk, they expressed more emotional responses, both positive and negative, than when viewing any static graphic or numerical description of a risk. Their responses included relief about small risks and concern about large risks. The groups also commented on static graphics: arranging the figures affected by disease randomly throughout a group of figures made it more difficult to judge the proportion affected but was described as more realistic. Conclusions Interactive graphics appear to have potential for expressing risk magnitude as well as the affective feeling of risk. Quantitative studies are planned to assess the effect on perceived risks and estimated risk magnitudes. PMID:19657926

Eliciting affect via immersive virtual reality: a tool for adolescent risk reduction.

PubMed

Hadley, Wendy; Houck, Christopher D; Barker, David H; Garcia, Abbe Marrs; Spitalnick, Josh S; Curtis, Virginia; Roye, Scott; Brown, Larry K

2014-04-01

A virtual reality environment (VRE) was designed to expose participants to substance use and sexual risk-taking cues to examine the utility of VR in eliciting adolescent physiological arousal. 42 adolescents (55% male) with a mean age of 14.54 years (SD = 1.13) participated. Physiological arousal was examined through heart rate (HR), respiratory sinus arrhythmia (RSA), and self-reported somatic arousal. A within-subject design (neutral VRE, VR party, and neutral VRE) was utilized to examine changes in arousal. The VR party demonstrated an increase in physiological arousal relative to a neutral VRE. Examination of individual segments of the party (e.g., orientation, substance use, and sexual risk) demonstrated that HR was significantly elevated across all segments, whereas only the orientation and sexual risk segments demonstrated significant impact on RSA. This study provides preliminary evidence that VREs can be used to generate physiological arousal in response to substance use and sexual risk cues.

A systematic review of grandparents’ influence on grandchildren’s cancer risk factors

PubMed Central

2017-01-01

Many lifestyle patterns are established when children are young. Research has focused on the potential role of parents as a risk factor for non communicable disease in children, but there is limited investigation of the role of other caregivers, such as grandparents. The aim of this review was to identify and synthesise evidence for any influence grandparents’ care practices may have on their grandchildren’s long term cancer risk factors. A systematic review was carried out with searches across four databases (MEDLINE, Embase, Web of Science, PsycINFO) as well as searches of reference lists and citing articles, and Google Scholar. Search terms were based on six areas of risk that family care could potentially influence–weight, diet, physical activity, tobacco, alcohol and sun exposure. All study designs were included, as were studies that provided an indication of the interaction of grandparents with their grandchildren. Studies were excluded if grandparents were primary caregivers and if children had serious health conditions. Study quality was assessed using National Institute for Health and Care Excellence checklists. Grandparent impact was categorised as beneficial, adverse, mixed or as having no impact. Due to study heterogeneity a meta-analysis was not possible. Qualitative studies underwent a thematic synthesis of their results. Results from all included studies indicated that there was a sufficient evidence base for weight, diet, physical activity and tobacco studies to draw conclusions about grandparents’ influence. One study examined alcohol and no studies examined sun exposure. Evidence indicated that, overall, grandparents had an adverse impact on their grandchildren’s cancer risk factors. The theoretical work in the included studies was limited. Theoretically underpinned interventions designed to reduce these risk factors must consider grandparents’ role, as well as parents’, and be evaluated robustly to inform the evidence base further. PMID:29135979

Quality by design I: Application of failure mode effect analysis (FMEA) and Plackett-Burman design of experiments in the identification of "main factors" in the formulation and process design space for roller-compacted ciprofloxacin hydrochloride immediate-release tablets.

PubMed

Fahmy, Raafat; Kona, Ravikanth; Dandu, Ramesh; Xie, Walter; Claycamp, Gregg; Hoag, Stephen W

2012-12-01

As outlined in the ICH Q8(R2) guidance, identifying the critical quality attributes (CQA) is a crucial part of dosage form development; however, the number of possible formulation and processing factors that could influence the manufacturing of a pharmaceutical dosage form is enormous obviating formal study of all possible parameters and their interactions. Thus, the objective of this study is to examine how quality risk management can be used to prioritize the number of experiments needed to identify the CQA, while still maintaining an acceptable product risk profile. To conduct the study, immediate-release ciprofloxacin tablets manufactured via roller compaction were used as a prototype system. Granules were manufactured using an Alexanderwerk WP120 roller compactor and tablets were compressed on a Stokes B2 tablet press. In the early stages of development, prior knowledge was systematically incorporated into the risk assessment using failure mode and effect analysis (FMEA). The factors identified using FMEA were then followed by a quantitative assessed using a Plackett-Burman screening design. Results show that by using prior experience, literature data, and preformulation data the number of experiments could be reduced to an acceptable level, and the use of FMEA and screening designs such as the Plackett Burman can rationally guide the process of reducing the number experiments to a manageable level.

Prospective power calculations for the Four Lab study of a multigenerational reproductive/developmental toxicity rodent bioassay using a complex mixture of disinfection by-products in the low-response region.

PubMed

Dingus, Cheryl A; Teuschler, Linda K; Rice, Glenn E; Simmons, Jane Ellen; Narotsky, Michael G

2011-10-01

In complex mixture toxicology, there is growing emphasis on testing environmentally representative doses that improve the relevance of results for health risk assessment, but are typically much lower than those used in traditional toxicology studies. Traditional experimental designs with typical sample sizes may have insufficient statistical power to detect effects caused by environmentally relevant doses. Proper study design, with adequate statistical power, is critical to ensuring that experimental results are useful for environmental health risk assessment. Studies with environmentally realistic complex mixtures have practical constraints on sample concentration factor and sample volume as well as the number of animals that can be accommodated. This article describes methodology for calculation of statistical power for non-independent observations for a multigenerational rodent reproductive/developmental bioassay. The use of the methodology is illustrated using the U.S. EPA's Four Lab study in which rodents were exposed to chlorinated water concentrates containing complex mixtures of drinking water disinfection by-products. Possible experimental designs included two single-block designs and a two-block design. Considering the possible study designs and constraints, a design of two blocks of 100 females with a 40:60 ratio of control:treated animals and a significance level of 0.05 yielded maximum prospective power (~90%) to detect pup weight decreases, while providing the most power to detect increased prenatal loss.

Prospective Power Calculations for the Four Lab Study of A Multigenerational Reproductive/Developmental Toxicity Rodent Bioassay Using A Complex Mixture of Disinfection By-Products in the Low-Response Region

PubMed Central

Dingus, Cheryl A.; Teuschler, Linda K.; Rice, Glenn E.; Simmons, Jane Ellen; Narotsky, Michael G.

2011-01-01

In complex mixture toxicology, there is growing emphasis on testing environmentally representative doses that improve the relevance of results for health risk assessment, but are typically much lower than those used in traditional toxicology studies. Traditional experimental designs with typical sample sizes may have insufficient statistical power to detect effects caused by environmentally relevant doses. Proper study design, with adequate statistical power, is critical to ensuring that experimental results are useful for environmental health risk assessment. Studies with environmentally realistic complex mixtures have practical constraints on sample concentration factor and sample volume as well as the number of animals that can be accommodated. This article describes methodology for calculation of statistical power for non-independent observations for a multigenerational rodent reproductive/developmental bioassay. The use of the methodology is illustrated using the U.S. EPA’s Four Lab study in which rodents were exposed to chlorinated water concentrates containing complex mixtures of drinking water disinfection by-products. Possible experimental designs included two single-block designs and a two-block design. Considering the possible study designs and constraints, a design of two blocks of 100 females with a 40:60 ratio of control:treated animals and a significance level of 0.05 yielded maximum prospective power (~90%) to detect pup weight decreases, while providing the most power to detect increased prenatal loss. PMID:22073030

Diabetes and cardiovascular disease interventions by community pharmacists: a systematic review.

PubMed

Evans, Charity D; Watson, Erin; Eurich, Dean T; Taylor, Jeff G; Yakiwchuk, Erin M; Shevchuk, Yvonne M; Remillard, Alfred; Blackburn, David

2011-05-01

To systematically review and assess the quality of studies evaluating community pharmacist interventions for preventing or managing diabetes or cardiovascular disease (CVD) and/or their major risk factors. A comprehensive literature search was performed using MEDLINE (1950-February 2011), EMBASE (1980-February 2011), International Pharmaceutical Abstracts (1970-February 2011), Cumulative Index to Nursing and Allied Health Literature (1982-June 2007), and Cochrane Central Register of Controlled Trials (1898-February 2011). Search terms included: community pharmacy(ies), community pharmacist(s), cardiovascular, diabetes, and intervention. The grey literature was searched using the ProQuest Dissertations and Theses, Theses Canada, and OAlster databases. Articles published in English or French with all study designs were considered for the review. Studies were included if they contained interventions designed to reduce the incidence, risk, or mortality of CVD or diabetes; affect clinical indicators of CVD or diabetes mellitus (including hypertension, dyslipidemia, or hemoglobin A(1c)); and/or improve adherence to treatment strategies. Only studies involving interventions carried out primarily by pharmacists in community pharmacy settings were included. Study quality was assessed using a checklist validated for both randomized and nonrandomized studies. A total of 4142 studies were initially identified, with 40 meeting our inclusion criteria. Eleven studies were randomized controlled trials, 4 were cluster randomized trials, and 2 studies had randomized before-after designs. The remaining studies were controlled before-after (n = 2), cohort (n = 4), and uncontrolled before-after (n = 17) designs. Interventions focused on diabetes (n = 12), hypertension (n = 9), medication adherence (n = 9), lipids (n = 5), evidence-based medication initiation or optimization (n = 3), risk factor prediction scores (n = 1), and body mass index (n = 1). All studies contained interventions focused at the patient level and the majority of studies (34/40) involved interventions directed at both the physician and patient. No specific intervention emerged as superior, and study quality was generally poor, making it difficult to determine the true effect of the interventions. Poor study quality, time-intensive interventions, and unproven clinical significance warrant the need for further high-quality studies of community pharmacist interventions for preventing or managing diabetes or CVD and/or their major risk factors.

Antidepressant Exposure During Pregnancy and Risk of Autism in the Offspring, 2: Do the New Studies Add Anything New?

PubMed

Andrade, Chittaranjan

During the past year, at least 5 new studies, all observational in design, examined the risk of autism spectrum disorder (ASD) in children exposed to antidepressant medication in utero. These studies had not found inclusion in the many systematic reviews and meta-analyses that had also been published in the past year. Noteworthy methods and findings of the new studies are summarized. One of these studies is examined in detail to help the reader understand methodological and conceptual issues that are critical in the field. Some general caveats in the interpretation of the literature are also discussed. In order to reduce the limitations associated with their observational design, the new studies used many innovations, including maternal controls with mental illness, propensity score-matched controls, preconception antidepressant exposure controls, sibling controls, paternal antidepressant user controls, and modeling for the presence of an unknown confound. Two studies found an association between maternal antidepressant use during pregnancy and the risk of ASD in the offspring; these associations remained statistically significant even after covariate adjustments. The other 3 studies found that the significant association between antidepressant exposure and ASD risk was lost after statistical adjustment; that preconception antidepressant exposure was also associated with increased risk of ASD; that siblings discordant for antidepressant exposure had similar ASD risk; and that paternal antidepressant use was also associated with increased risk. The new studies do not change the conclusions of the available meta-analyses. In fact, at least some of the new data strengthen the conclusion that antidepressant use during pregnancy is likely to be a marker of more severe illness and that inadequately measured, unmeasured, or unknown genetic, behavioral, and environmental confounds associated with more severe illness (rather than the antidepressant exposure by itself) may be responsible for the increased risk of ASD. © Copyright 2017 Physicians Postgraduate Press, Inc.

75 FR 80821 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-23

... statement to read: Three comments were received that expressed support for the research and recommended... design. Specifically, we agree that the study design should include the variables of age, education... another study (FDA-2009-N-0263 (January 5, 2010), ``Presentation of Quantitative Effectiveness and Risk...

A Twin Study of Objective and Subjective Pubertal Timing and Peer Influence on Risk-Taking.

PubMed

Kretsch, Natalie; Mendle, Jane; Harden, K Paige

2016-03-01

The current study used a behavioral genetic design to test whether three measures of pubertal timing moderated peer influence on risk-taking in a sample of 248 female adolescent twin pairs ( M age =16.0, SD =1.5) from the National Longitudinal Study of Adolescent Health. Peer influence was operationalized as the quasi-causal association between girls' self-reported risk-taking and the risk-taking reported by their friends. Girls with earlier ages at menarche and who perceived themselves as more developed than peers were more susceptible to peer influence on risk-taking. However, age-standardized ratings of body changes did not moderate peer influence. This study highlights distinctions between multiple measures of pubertal timing, using an innovative synthesis of genetically informative data and peer nomination data.

A Twin Study of Objective and Subjective Pubertal Timing and Peer Influence on Risk-Taking

PubMed Central

Kretsch, Natalie; Mendle, Jane; Harden, K. Paige

2014-01-01

The current study used a behavioral genetic design to test whether three measures of pubertal timing moderated peer influence on risk-taking in a sample of 248 female adolescent twin pairs (Mage=16.0, SD=1.5) from the National Longitudinal Study of Adolescent Health. Peer influence was operationalized as the quasi-causal association between girls' self-reported risk-taking and the risk-taking reported by their friends. Girls with earlier ages at menarche and who perceived themselves as more developed than peers were more susceptible to peer influence on risk-taking. However, age-standardized ratings of body changes did not moderate peer influence. This study highlights distinctions between multiple measures of pubertal timing, using an innovative synthesis of genetically informative data and peer nomination data. PMID:27026753

Personal, social and environmental risk factors of problematic gambling among high school adolescents in Addis Ababa, Ethiopia.

PubMed

Abdi, Tariku A; Ruiter, Robert A C; Adal, Tamirie A

2015-03-01

Understanding risk factors of problematic gambling is prerequisite to effective intervention design to alleviate the negative consequences of gambling. This study explored the personal, social and environmental risk factors of problematic gambling in four high schools in Addis Ababa, Ethiopia, among students (N = 422) ranging from 12 to 21 years of age. Results from the cross-sectional survey showed that personal feelings (e.g., self-esteem, false perceptions about winning, drug abuse), social factors (e.g., peer influence, parental gambling), and environmental factors (e.g., accessibility of gambling venues, advertisements) were significant correlates of problematic gambling. The study also revealed that men were more at risk for severe problematic gambling than females. Among the identified types of gambling activities, the most prevalent ones were playing cards followed by flipping coin and pool gambling while internet gambling was among the least reported gambling activities. By identifying personal, social and environmental correlates of risky gambling activities this study provides evidence-based information for the systematic design and evaluation of educational interventions to prevent problematic gambling in young people.

Personal, Social and Environmental Risk Factors of Problematic Gambling Among High School Adolescents in Addis Ababa, Ethiopia.

PubMed

Abdi, Tariku A; Ruiter, Robert A C; Adal, Tamirie A

2013-09-29

Understanding risk factors of problematic gambling is prerequisite to effective intervention design to alleviate the negative consequences of gambling. This study explored the personal, social and environmental risk factors of problematic gambling in four high schools in Addis Ababa, Ethiopia, among students (N = 422) ranging from 12 to 21 years of age. Results from the cross-sectional survey showed that personal feelings (e.g., self-esteem, false perceptions about winning, drug abuse), social factors (e.g., peer influence, parental gambling), and environmental factors (e.g., accessibility of gambling venues, advertisements) were significant correlates of problematic gambling. The study also revealed that men were more at risk for severe problematic gambling than females. Among the identified types of gambling activities, the most prevalent ones were playing cards followed by flipping coin and pool gambling while internet gambling was among the least reported gambling activities. By identifying personal, social and environmental correlates of risky gambling activities this study provides evidence-based information for the systematic design and evaluation of educational interventions to prevent problematic gambling in young people.

Factors influencing HIV-risk behaviors among HIV-positive urban African Americans.

PubMed

Plowden, Keith O; Fletcher, Audwin; Miller, J Lawrence

2005-01-01

Urban African Americans are disproportionately affected by HIV, the virus associated with AIDS. Although incidence and mortality appear to be decreasing in some populations, they continue to remain steady among inner-city African Americans. A major concern is the number of HIV-positive individuals who continue to practice high-risk behaviors. Understanding factors that increase risks is essential for the development and implementation of effective prevention initiatives. Following a constructionist epistemology, this study used ethnography to explore social and cultural factors that influence high-risk behaviors among inner-city HIV-positive African Americans. Leininger's culture care diversity and universality theory guided the study. Individual qualitative interviews were conducted with HIV-positive African Americans in the community to explore social and cultural factors that increase HIV-risky behaviors. For this study, family/kinship, economic, and education factors played a significant role in risky behaviors. Reducing HIV disparity among African Americans is dependent on designing appropriate interventions that enhance protective factors. Clinicians providing care to HIV-positive individuals can play a key role in reducing transmission by recognizing and incorporating these factors when designing effective prevention interventions.

The epidemiology of injury among surfers, kite surfers and personal watercraft riders: wind and waves.

PubMed

Pikora, Terri J; Braham, Rebecca; Mills, Christina

2012-01-01

The objective of this review was to summarize the epidemiological literature for surfboard riding (surfing), kite surfing and personal watercraft (PWC) riding injuries and describe the incidence and nature of these injuries, common risk factors, and strategies for prevention. The databases searched for relevant publications included Medline, ScienceDirect, ProQuest International, PubMed, Academic Search Premier as well as Google Scholar to identify additional, non-indexed studies. Overall, there was a lack of good quality descriptive studies for these three sports and many of the studies reviewed involved the use of administrative datasets or case-series designs. Among the few studies to provide incidence estimates, there were inconsistencies in how injury was defined, the inclusion criteria, and the reporting of incidence rates, making comparisons within and between the sports difficult. While the reported incidence rates were generally low, head and lower extremity injuries were common across all three sports. Only two studies reported evidence for postulated risk factors. Bigger waves and surfing over rock or reef sea floor increased the risk of injury among competitive surfers, while older age and having more experience increased the risk of significant injuries among recreational surfers. No evaluations of preventative measures were identified. This review demonstrates the need for well-designed epidemiological research, especially studies that focus on the accurate measurement and description of incidence, nature, severity and circumstances of injuries. Once this has occurred, interventions targeted at reducing the incidence of injuries among these sports can be designed, implemented and evaluated. Copyright © 2012 S. Karger AG, Basel.

The Female Athlete Body (FAB) study: Rationale, design, and baseline characteristics.

PubMed

Stewart, Tiffany M; Pollard, Tarryn; Hildebrandt, Tom; Beyl, Robbie; Wesley, Nicole; Kilpela, Lisa Smith; Becker, Carolyn Black

2017-09-01

Eating Disorders (EDs) are serious psychiatric illnesses marked by psychiatric comorbidity, medical complications, and functional impairment. Research indicates that female athletes are often at greater risk for developing ED pathology versus non-athlete females. The Female Athlete Body (FAB) study is a three-site, randomized controlled trial (RCT) designed to assess the efficacy of a behavioral ED prevention program for female collegiate athletes when implemented by community providers. This paper describes the design, intervention, and participant baseline characteristics. Future papers will discuss outcomes. Female collegiate athletes (N=481) aged 17-21 were randomized by site, team, and sport type to either FAB or a waitlist control group. FAB consisted of three sessions (1.3h each) of a behavioral ED prevention program. Assessments were conducted at baseline (pre-intervention), post-intervention (3weeks), and six-, 12-, and 18-month follow-ups. This study achieved 96% (N=481) of target recruitment (N=500). Few group differences emerged at baseline. Total sample analyses revealed moderately low baseline instances of ED symptoms and clinical cases. Health risks associated with EDs necessitate interventions for female athletes. The FAB study is the largest existing RCT for female athletes aimed at both reduction of ED risk factors and ED prevention. The methods presented and population recruited for this study represent an ideal intervention for assessing the effects of FAB on both the aforementioned outcomes. We anticipate that findings of this study (reported in future papers) will make a significant contribution to the ED risk factor reduction and prevention literature. Copyright © 2017 Elsevier Inc. All rights reserved.

Limitations of self-care in reducing the risk of lymphedema: supportive-educative systems.

PubMed

Armer, Jane M; Brooks, Constance W; Stewart, Bob R

2011-01-01

The purpose of this study was to examine patient perceptions of limitations related to self-care measures to reduce lymphedema risk following breast cancer surgery. Secondary analysis of survey data from a companion study to a study piloting a behavioral-educational intervention was conducted to examine the specific limitations in performing lymphedema risk-reduction self-care measures. Findings suggest a more comprehensive approach is needed if patients are to engage in self-care actions to reduce lymphedema risk. Understanding the concepts of self-care and personal support interventions that include motivational interviewing can help nurses design supportive-educative care systems that assist patients in overcoming limitations in the estimative, transitional, and productive phases of self-care necessary to reduce lymphedema risk.

Creating the Action Model for High Risk Infant Follow Up Program in Iran.

PubMed

Heidarzadeh, Mohammad; Jodiery, Behzad; Mirnia, Kayvan; Akrami, Forouzan; Hosseini, Mohammad Bagher; Heidarabadi, Seifollah; HabibeLahi, Abbas

2013-11-01

Intervention in early childhood development as one of the social determinants of health, is important for reducing social gap and inequity. In spite of increasingly developing intensive neonatal care wards and decreasing neonatal mortality rate, there is no follow up program in Iran. This study was carreid out to design high risk infants follow up care program with the practical aim of creating an model action for whole country, in 2012. This qualitative study has been done by the Neonatal Department of the Deputy of Public Health in cooperation with Pediatrics Health Research Center of Tabriz University of Medical Sciences, Iran. After study of international documents, consensus agreement about adapted program for Iran has been accomplished by focus group discussion and attended Delphi agreement technique. After compiling primary draft included evidence based guidelines and executive plan, 14 sessions including expert panels were hold to finalize the program. After finalizing the program, high risk infants follow up care service package has been designed in 3 chapters: Evidence based clinical guidelines; eighteen main clinical guidelines and thirteen subsidiaries clinical guidelines, executive plan; 6 general, 6 following up and 5 backup processes. Education program including general and especial courses for care givers and follow up team, and family education processes. We designed and finalized high risk infants follow up care service package. It seems to open a way to extend it to whole country.

The QUALYOR (QUalité Osseuse LYon Orléans) study: a new cohort for non invasive evaluation of bone quality in postmenopausal osteoporosis. Rationale and study design.

PubMed

Chapurlat, Roland; Pialat, Jean-Baptiste; Merle, Blandine; Confavreux, Elisabeth; Duvert, Florence; Fontanges, Elisabeth; Khacef, Farida; Peres, Sylvie Loiseau; Schott, Anne-Marie; Lespessailles, Eric

2017-12-27

The diagnostic performance of densitometry is inadequate. New techniques of non-invasive evaluation of bone quality may improve fracture risk prediction. Testing the value of these techniques is the goal of the QUALYOR cohort. The bone mineral density (BMD) of postmenopausal women who sustain osteoporotic fracture is generally above the World Health Organization definition for osteoporosis. Therefore, new approaches to improve the detection of women at high risk for fracture are warranted. We have designed and recruited a new cohort to assess the predictive value of several techniques to assess bone quality, including high-resolution peripheral quantitative computerized tomography (HRpQCT), hip QCT, calcaneus texture analysis, and biochemical markers. We have enrolled 1575 postmenopausal women, aged at least 50, with an areal BMD femoral neck or lumbar spine T-score between - 1.0 and - 3.0. Clinical risk factors for fracture have been collected along with serum and blood samples. We describe the design of the QUALYOR study. Among these 1575 women, 80% were aged at least 60. The mean femoral neck T-score was - 1.6 and the mean lumbar spine T-score was -1.2. This cohort is currently being followed up. QUALYOR will provide important information on the relationship between bone quality variables and fracture risk in women with moderately decreased BMD.

Influence of information about specific absorption rate (SAR) upon customers' purchase decisions and safety evaluation of mobile phones.

PubMed

Wiedemann, Peter M; Schütz, Holger; Clauberg, Martin

2008-02-01

This study investigated whether the SAR value is a purchase-relevant characteristic of mobile phones for laypersons and what effect the disclosure of a precautionary SAR value has on laypersons' risk perception. The study consisted of two parts: Study part 1 used a conjoint analysis design to explore the relevance of the SAR value and other features of mobile phones for an intended buying decision. Study part 2 used an experimental, repeated measures design to examine the effect of the magnitude of SAR values and the disclosure of a precautionary SAR value on risk perception. In addition, the study included an analysis of prior concerns of the study participants with regard to mobile phone risks. Part 1 indicates that the SAR value has a high relevance for laypersons' purchase intentions. In the experimental purchase setting it ranks even before price and equipment features. The results of study part 2 show that providing information of a precautionary limit value does not influence risk perception. This result suggests that laypersons' underlying subjective "safety model" for mobile phones resembles more a "margin of safety" concept than a threshold concept. The latter observation holds true no matter how concerned the participants are. (c) 2007 Wiley-Liss, Inc.

Ability of HIV Advocacy to Modify Behavioral Norms and Treatment Impact: A Systematic Review.

PubMed

Sunguya, Bruno F; Munisamy, Murallitharan; Pongpanich, Sathirakorn; Yasuoka, Junko; Jimba, Masamine

2016-08-01

HIV advocacy programs are partly responsible for the global community's success in reducing the burden of HIV. The rising wave of the global burden of noncommunicable diseases (NCDs) has prompted the World Health Organization to espouse NCD advocacy efforts as a possible preventive strategy. HIV and NCDs share some similarities in their chronicity and risky behaviors, which are their associated etiology. Therefore, pooled evidence on the effectiveness of HIV advocacy programs and ideas shared could be replicated and applied during the conceptualization of NCD advocacy programs. Such evidence, however, has not been systematically reviewed to address the effectiveness of HIV advocacy programs, particularly programs that aimed at changing public behaviors deemed as risk factors. To determine the effectiveness of HIV advocacy programs and draw lessons from those that are effective to strengthen future noncommunicable disease advocacy programs. We searched for evidence regarding the effectiveness of HIV advocacy programs in medical databases: PubMed, The Cumulative Index to Nursing and Allied Health Literature Plus, Educational Resources and Information Center, and Web of Science, with articles dated from 1994 to 2014. Search criteria. The review protocol was registered before this review. The inclusion criteria were studies on advocacy programs or interventions. We selected studies with the following designs: randomized controlled design studies, pre-post intervention studies, cohorts and other longitudinal studies, quasi-experimental design studies, and cross-sectional studies that reported changes in outcome variables of interest following advocacy programs. We constructed Boolean search terms and used them in PubMed as well as other databases, in line with a population, intervention, comparator, and outcome question. The flow of evidence search and reporting followed the standard Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines. We selected 2 outcome variables (i.e., changing social norms and a change in impact) out of 6 key outcomes of advocacy interventions. We assessed the risk of bias for all selected studies by using the Cochrane risk-of-bias tool for randomized studies and using the Risk of Bias for Nonrandomized Observational Studies for observational studies. We did not grade the collective quality of evidence because of differences between the studies, with regard to methods, study designs, and context. Moreover, we could not carry out meta-analyses because of heterogeneity and the diverse study designs; thus, we used a narrative synthesis to report the findings. A total of 25 studies were eligible, of the 1463 studies retrieved from selected databases. Twenty-two of the studies indicated a shift in social norms as a result of HIV advocacy programs, and 3 indicated a change in impact. We drew 6 lessons from these programs that may be useful for noncommunicable disease advocacy: (1) involving at-risk populations in advocacy programs, (2) working with laypersons and community members, (3) working with peer advocates and activists, (4) targeting specific age groups and asking support from celebrities, (5) targeting several, but specific, risk factors, and (6) using an evidence-based approach through formative research. Author conclusions. HIV advocacy programs have been effective in shifting social norms and facilitating a change in impact. The lessons learned from these effective programs could be used to improve the design and implementation of future noncommunicable disease advocacy programs.

Urban Tree Risk Management:A Community Guide to Program Design and Implementation

Treesearch

Jill Pokorny; Joseph O' Brien; Richard Hauer; Gary Johnson; Jana Albers; Peter Bedker; Manfred Mielke

2003-01-01

Urban Tree Risk Management: A Community Guide to Program Design and Implementation is a fully illustrated, easy to read training manual written for community leaders, administrators, city foresters, parks and public works staff, and private tree care practitioners. The manual is designed to assist communities design, adopt and implement tree risk management programs,...

Understanding Sociocultural Factors Contributing to HIV Risk Among Ayoreo Bolivian Sex Workers.

PubMed

López Entrambasaguas, Olga María; Granero-Molina, José; Hernández-Padilla, Jose; Fernández-Sola, Cayetano

2015-01-01

The Bolivian indigenous Ayoreo ethnic people are vulnerable to sexually transmitted infections and HIV. Ayoreo women who also work in sex trades belong to an extremely high-risk group, and prevention programs are not delivering effective outcomes for them. The aim of our study was to explore, describe, and understand behavioral and cultural patterns related to sexual and reproductive health in Ayoreo sex workers. A qualitative-ethnographic study was designed; data were collected through participant observation and in-depth interviews with sex workers and key informants. Two fundamental themes contributing to HIV risk for female Ayoreo sex workers in Bolivia emerged: reproductive/sexual freedom and sociocultural risk determinants. We concluded that the in-depth examination of the sexual-reproductive culture amongst the Ayoreo has provided useful information, which might contribute to the cultural adaptation and design of future policies and prevention programs for sexually transmitted infections and HIV in this group. Copyright © 2015 Association of Nurses in AIDS Care. Published by Elsevier Inc. All rights reserved.

Probabilistic cost-benefit analysis of disaster risk management in a development context.

PubMed

Kull, Daniel; Mechler, Reinhard; Hochrainer-Stigler, Stefan

2013-07-01

Limited studies have shown that disaster risk management (DRM) can be cost-efficient in a development context. Cost-benefit analysis (CBA) is an evaluation tool to analyse economic efficiency. This research introduces quantitative, stochastic CBA frameworks and applies them in case studies of flood and drought risk reduction in India and Pakistan, while also incorporating projected climate change impacts. DRM interventions are shown to be economically efficient, with integrated approaches more cost-effective and robust than singular interventions. The paper highlights that CBA can be a useful tool if certain issues are considered properly, including: complexities in estimating risk; data dependency of results; negative effects of interventions; and distributional aspects. The design and process of CBA must take into account specific objectives, available information, resources, and the perceptions and needs of stakeholders as transparently as possible. Intervention design and uncertainties should be qualified through dialogue, indicating that process is as important as numerical results. © 2013 The Author(s). Journal compilation © Overseas Development Institute, 2013.

Non-psychotropic medication and risk of suicide or attempted suicide: a systematic review

PubMed Central

Gorton, Hayley C; Webb, Roger T; Kapur, Navneet; Ashcroft, Darren M

2016-01-01

Objectives To establish which non-psychotropic medications have been assessed in relation to risk of suicide or attempted suicide in observational studies, document reported associations and consider study strengths and limitations. Design Systematic review. Methods Four databases (Embase, Medline, PsycINFO and International Pharmaceutical Abstracts) were searched from 1990 to June 2014, and reference lists of included articles were hand-searched. Case–control, cohort and case only studies which reported suicide or attempted suicide in association with any non-psychotropic medication were included. Outcome measures The outcomes eligible for inclusion were suicide and attempted suicide, as defined by the authors of the included study. Results Of 11 792 retrieved articles, 19 were eligible for inclusion. Five studies considered cardiovascular medication and antiepileptics; two considered leukotriene receptor antagonists, isotretinoin and corticosteroids; one assessed antibiotics and another assessed varenicline. An additional study compared multiple medications prescribed to suicide cases versus controls. There was marked heterogeneity in study design, outcome and exposure classification, and control for confounding factors; particularly comorbid mental and physical illness. No increased risk was associated with cardiovascular medications, but associations with other medications remained inconclusive and meta-analysis was inappropriate due to study heterogeneity. Conclusions Whether non-psychotropic medications are associated with increased risk of suicide or attempted suicide remains largely unknown. Robust identification of suicide outcomes and control of comorbidities could improve quantification of risk associated with non-psychotropic medication, beyond that conferred by underlying physical and mental illnesses. PMID:26769782

Review of the literature on benzene exposure and leukemia subtypes.

PubMed

Schnatter, A Robert; Rosamilia, Kim; Wojcik, Nancy C

2005-05-30

The epidemiologic literature on benzene exposure and leukemia in the MEDLINE and TOXNET databases was examined through October 2004 using the keywords "benzene", "leukemia" and "adverse health effects". This search was complemented by reviewing the reference lists from extant literature reviews and criteria documents on benzene. Published studies were characterized according to the type of industry studied and design, exposure assessment, disease classification, and control for confounding variables. Study design consisted of either cohort studies or case-control studies, which were further categorized into population-based and nested case-control studies. Disease classification considered the source of diagnostic information, whether there was clinical confirmation from medical records or histopathological, morphological and/or cytogenetic reviews, and as to whether the International Classification of Diseases (ICD) or the French-American-British (FAB) schemes were used (no studies used the Revised European-American Lymphoma (REAL) classification scheme). Nine cohort and 13 case-control studies met inclusion criteria for this review. High and significant acute myeloid leukemia risks with positive dose response relationships were identified across study designs, particularly in the "well-conducted" cohort studies and especially in more highly exposed workers in rubber, shoe, and paint industries. Risks for chronic lymphocytic leukemia (CLL) tended to show elevations in nested case-control studies, with possible dose response relationships in at least two of the three studies. However, cohort studies on CLL show no such risks. Data for chronic myeloid leukemia and acute lymphocytic leukemia are sparse and inconclusive.

SSRIs and risk of suicide attempts in young people - A Danish observational register-based historical cohort study, using propensity score.

PubMed

Christiansen, Erik; Agerbo, Esben; Bilenberg, Niels; Stenager, Elsebeth

2016-01-01

SSRIs are widely used in the treatment of mental illness for both children and adults. Studies have found a slightly increased risk of suicidal thoughts and suicide attempts in young people using SSRIs but SSRIs' impact on risk for suicides in youth is not well-established. Is there indication that SSRIs might raise risk for suicide attempts in young people? We used an observational register-based historical cohort design, a large cohort of all Danish individuals born in 1983-1989 (n = 392,458) and a propensity score approach to analyse the impact from SSRIs on risk for suicide attempts. Every suicide attempt and redeemed prescription of SSRIs was analysed by Cox regression. We found a significant overlap between redeeming a prescription on SSRIs and subsequent suicide attempt. The risk for suicide attempt was highest in the first 3 months after redeeming the first prescription. The hazard ratio for suicide attempts after redeeming a prescription was estimated to 5.23, 95% CI 4.82-5.68. We conclude that the risk of suicide attempt is higher for young people in the first months after redeeming their first prescription for SSRIs, compared to non-users. For SSRI users with lower propensity score (fewer risk factors for SSRIs) the risk of suicide attempt is estimated to be highest. Although the design may miss some explicit reason for prescription of SSRIs and SSRIs might be a marker for those in high risk rather than a causal risk factor, we would recommend systematic risk assessment in the period after redeeming the first prescription.

Association Between Barracks Type and Acute Respiratory Infection in a Gender Integrated Army Basic Combat Training Population

PubMed Central

White, Duvel W.; Feigley, Charles E.; McKeown, Robert E.; Hout, Joseph J.; Hebert, James R.

2015-01-01

Background Acute respiratory infections (ARIs) are the leading cause of acute morbidity and lost work time in the United States. Few studies have looked at building design and transmission of ARIs. Objectives This study explores the association of ventilation design, room occupancy numbers, and training week with ARI rates in Army Basic Combat Training barracks. Methods This observational study captured the overall incidence of ARI in a cohort of 16,258 individuals attending basic combat training at Fort Jackson, South Carolina. Results ARI risk was higher among trainees living in the 60-person room barracks compared with those living in 8-person rooms, which increased rapidly for the first few weeks of training and then declined to baseline. Conclusions Findings support direct contact as primary ARI transmission mode in this study population based on observed lower ARI risk in smaller room barracks and similar risk in large room barracks despite heating, ventilation, and air conditioning system variability. PMID:21882781

Sampling design for the Study of Cardiovascular Risks in Adolescents (ERICA).

PubMed

Vasconcellos, Mauricio Teixeira Leite de; Silva, Pedro Luis do Nascimento; Szklo, Moyses; Kuschnir, Maria Cristina Caetano; Klein, Carlos Henrique; Abreu, Gabriela de Azevedo; Barufaldi, Laura Augusta; Bloch, Katia Vergetti

2015-05-01

The Study of Cardiovascular Risk in Adolescents (ERICA) aims to estimate the prevalence of cardiovascular risk factors and metabolic syndrome in adolescents (12-17 years) enrolled in public and private schools of the 273 municipalities with over 100,000 inhabitants in Brazil. The study population was stratified into 32 geographical strata (27 capitals and five sets with other municipalities in each macro-region of the country) and a sample of 1,251 schools was selected with probability proportional to size. In each school three combinations of shift (morning and afternoon) and grade were selected, and within each of these combinations, one class was selected. All eligible students in the selected classes were included in the study. The design sampling weights were calculated by the product of the reciprocals of the inclusion probabilities in each sampling stage, and were later calibrated considering the projections of the numbers of adolescents enrolled in schools located in the geographical strata by sex and age.

BiomarCaRE: rationale and design of the European BiomarCaRE project including 300,000 participants from 13 European countries.

PubMed

Zeller, Tanja; Hughes, Maria; Tuovinen, Tarja; Schillert, Arne; Conrads-Frank, Annette; Ruijter, Hester den; Schnabel, Renate B; Kee, Frank; Salomaa, Veikko; Siebert, Uwe; Thorand, Barbara; Ziegler, Andreas; Breek, Heico; Pasterkamp, Gerard; Kuulasmaa, Kari; Koenig, Wolfgang; Blankenberg, Stefan

2014-10-01

Biomarkers are considered as tools to enhance cardiovascular risk estimation. However, the value of biomarkers on risk estimation beyond European risk scores, their comparative impact among different European regions and their role towards personalised medicine remains uncertain. Biomarker for Cardiovascular Risk Assessment in Europe (BiomarCaRE) is an European collaborative research project with the primary objective to assess the value of established and emerging biomarkers for cardiovascular risk prediction. BiomarCaRE integrates clinical and epidemiological biomarker research and commercial enterprises throughout Europe to combine innovation in biomarker discovery for cardiovascular disease prediction with consecutive validation of biomarker effectiveness in large, well-defined primary and secondary prevention cohorts including over 300,000 participants from 13 European countries. Results from this study will contribute to improved cardiovascular risk prediction across different European populations. The present publication describes the rationale and design of the BiomarCaRE project.

Rationale and design of the vitamin D and type 2 diabetes (D2d) study: a diabetes prevention trial

USDA-ARS?s Scientific Manuscript database

OBJECTIVE: Observational studies suggest that vitamin D may lower the risk of type 2 diabetes. However, data from long-term trials are lacking. The Vitamin D and Type 2 Diabetes (D2d) study is a randomized clinical trial designed to examine whether a causal relationship exists between vitamin D supp...

Risk analysis of computer system designs

NASA Technical Reports Server (NTRS)

Vallone, A.

1981-01-01

Adverse events during implementation can affect final capabilities, schedule and cost of a computer system even though the system was accurately designed and evaluated. Risk analysis enables the manager to forecast the impact of those events and to timely ask for design revisions or contingency plans before making any decision. This paper presents a structured procedure for an effective risk analysis. The procedure identifies the required activities, separates subjective assessments from objective evaluations, and defines a risk measure to determine the analysis results. The procedure is consistent with the system design evaluation and enables a meaningful comparison among alternative designs.

2015 Space Human Factors Engineering Standing Review Panel

NASA Technical Reports Server (NTRS)

Steinberg, Susan

2015-01-01

The 2015 Space Human Factors Engineering (SHFE) Standing Review Panel (from here on referred to as the SRP) met for a site visit in Houston, TX on December 2 - 3, 2015. The SRP reviewed the updated research plans for the Risk of Inadequate Design of Human and Automation/Robotic Integration (HARI Risk), the Risk of Inadequate Human-Computer Interaction (HCI Risk), and the Risk of Inadequate Mission, Process and Task Design (MPTask Risk). The SRP also received a status update on the Risk of Incompatible Vehicle/Habitat Design (Hab Risk) and the Risk of Performance Errors Due to Training Deficiencies (Train Risk). The SRP is pleased with the progress and responsiveness of the SHFE team. The presentations were much improved this year. The SRP is also pleased with the human-centered design approach. Below are some of the more extensive comments from the SRP. We have also made comments in each section concerning gaps/tasks in each. The comments below reflect more significant changes that impact more than just one particular section.

A method for scenario-based risk assessment for robust aerospace systems

NASA Astrophysics Data System (ADS)

Thomas, Victoria Katherine

In years past, aircraft conceptual design centered around creating a feasible aircraft that could be built and could fly the required missions. More recently, aircraft viability entered into conceptual design, allowing that the product's potential to be profitable should also be examined early in the design process. While examining an aerospace system's feasibility and viability early in the design process is extremely important, it is also important to examine system risk. In traditional aerospace systems risk analysis, risk is examined from the perspective of performance, schedule, and cost. Recently, safety and reliability analysis have been brought forward in the design process to also be examined during late conceptual and early preliminary design. While these analyses work as designed, existing risk analysis methods and techniques are not designed to examine an aerospace system's external operating environment and the risks present there. A new method has been developed here to examine, during the early part of concept design, the risk associated with not meeting assumptions about the system's external operating environment. The risks are examined in five categories: employment, culture, government and politics, economics, and technology. The risks are examined over a long time-period, up to the system's entire life cycle. The method consists of eight steps over three focus areas. The first focus area is Problem Setup. During problem setup, the problem is defined and understood to the best of the decision maker's ability. There are four steps in this area, in the following order: Establish the Need, Scenario Development, Identify Solution Alternatives, and Uncertainty and Risk Identification. There is significant iteration between steps two through four. Focus area two is Modeling and Simulation. In this area the solution alternatives and risks are modeled, and a numerical value for risk is calculated. A risk mitigation model is also created. The four steps involved in completing the modeling and simulation are: Alternative Solution Modeling, Uncertainty Quantification, Risk Assessment, and Risk Mitigation. Focus area three consists of Decision Support. In this area a decision support interface is created that allows for game playing between solution alternatives and risk mitigation. A multi-attribute decision making process is also implemented to aid in decision making. A demonstration problem inspired by Airbus' mid 1980s decision to break into the widebody long-range market was developed to illustrate the use of this method. The results showed that the method is able to capture additional types of risk than previous analysis methods, particularly at the early stages of aircraft design. It was also shown that the method can be used to help create a system that is robust to external environmental factors. The addition of an external environment risk analysis in the early stages of conceptual design can add another dimension to the analysis of feasibility and viability. The ability to take risk into account during the early stages of the design process can allow for the elimination of potentially feasible and viable but too-risky alternatives. The addition of a scenario-based analysis instead of a traditional probabilistic analysis enabled uncertainty to be effectively bound and examined over a variety of potential futures instead of only a single future. There is also potential for a product to be groomed for a specific future that one believes is likely to happen, or for a product to be steered during design as the future unfolds.

Risk levels for suffering a traffic injury in primary health care. The LESIONAT* project

PubMed Central

2010-01-01

Background Literature shows that not only are traffic injuries due to accidents, but that there is also a correlation between different chronic conditions, the consumption of certain types of drugs, the intake of psychoactive substances and the self perception of risk (Health Belief Model) and the impact/incidence of traffic accidents. There are few studies on these aspects in primary health care. The objectives of our study are: Main aim: To outline the distribution of risk factors associated with Road Traffic Injuries (RTI) in a driving population assigned to a group of primary health care centres in Barcelona province. Secondly, we aim to study the distribution of diverse risk factors related to the possibility of suffering an RTI according to age, sex and population groups, to assess the relationship between these same risk factors and self risk perception for suffering an RTI, and to outline the association between the number of risk factors and the history of reported collisions. Methods/Design Design: Cross-sectional, multicentre study. Setting: 25 urban health care centres. Study population: Randomly selected sample of Spanish/Catalan speakers age 16 or above with a medical register in any of the 25 participating primary health care centres. N = 1540. Unit of study: Basic unit of care, consisting of a general practitioner and a nurse, both of whom caring for the same population (1,500 to 2,000 people per unit). Instruments of measurement: Data collection will be performed using a survey carried out by health professionals, who will use the clinical registers and the information reported by the patient during the visit to collect the baseline data: illnesses, medication intake, alcohol and psychoactive consumption, and self perception of risk. Discussion We expect to obtain a risk profile of the subjects in relation to RTI in the primary health care field, and to create a group for a prospective follow-up. Trial Registration Clinical Trials.gov Identifier: NCT00778440. PMID:20233403

What is killing? People's knowledge about coronary heart disease, attitude towards prevention and main risk reduction barriers in Ismailia, Egypt (descriptive cross-sectional study).

PubMed

Seef, Sameh; Jeppsson, Anders; Stafström, Martin

2013-01-01

Cardiovascular diseases are a public health concern everywhere, especially ischemic or coronary heart diseases (CHD) which are on top of causes list of mortality and morbidity in both genders globally. From which nearly 80% can be because of modifiable risks. In Egypt, there is a lack of studies on the knowledge of people about coronary heart diseases and its modifiable risks. So, this research reported here we designed to measure the dimensions of peoples knowledge about CHD and their attitude towards prevention, and to identify the main risk reduction barriers. By using comprehensive cross-sectional, descriptive research design, all adult individuals attending the family health clinic at Suez Canal University Hospital were eligible for inclusion with total number 125 participants. An interview questionnaire designed and used to collect data. The study revealed that (10.4%) of participants had a history of CHD, and (7.2%) had a family history of CHD. 79.2% Had a satisfactory total knowledge about CHD, and (94.4%) had a positive total attitude towards prevention. Risk reduction barriers as a medical setting barriers were (24%), patient related barriers were (22.4%). Community-societal barriers were almost the same as knowledge barriers which were around (16%). At last the systemic-organizational barriers were (9.6%). The findings settled that, total knowledge about CHD was satisfactory but lower than the level total of attitude. More effort the health system needs to improve the settings and engage patients in their plans and breaking related barriers, with development of health education programs based on needs assessment. Further studies we recommend to explore the reasons and follow up the changes.

Process characterization and Design Space definition.

PubMed

Hakemeyer, Christian; McKnight, Nathan; St John, Rick; Meier, Steven; Trexler-Schmidt, Melody; Kelley, Brian; Zettl, Frank; Puskeiler, Robert; Kleinjans, Annika; Lim, Fred; Wurth, Christine

2016-09-01

Quality by design (QbD) is a global regulatory initiative with the goal of enhancing pharmaceutical development through the proactive design of pharmaceutical manufacturing process and controls to consistently deliver the intended performance of the product. The principles of pharmaceutical development relevant to QbD are described in the ICH guidance documents (ICHQ8-11). An integrated set of risk assessments and their related elements developed at Roche/Genentech were designed to provide an overview of product and process knowledge for the production of a recombinant monoclonal antibody (MAb). This chapter describes the tools used for the characterization and validation of MAb manufacturing process under the QbD paradigm. This comprises risk assessments for the identification of potential Critical Process Parameters (pCPPs), statistically designed experimental studies as well as studies assessing the linkage of the unit operations. Outcome of the studies is the classification of process parameters according to their criticality and the definition of appropriate acceptable ranges of operation. The process and product knowledge gained in these studies can lead to the approval of a Design Space. Additionally, the information gained in these studies are used to define the 'impact' which the manufacturing process can have on the variability of the CQAs, which is used to define the testing and monitoring strategy. Copyright © 2016 International Alliance for Biological Standardization. Published by Elsevier Ltd. All rights reserved.

Design and analysis of post-marketing research.

PubMed

Zhou, Xiao-Hua Andrew; Yang, Wei

2013-07-01

A post-marketing study is an integral part of research that helps to ensure a favorable risk-benefit profile for approved drugs used in the market. Because most of post-marketing studies use observational designs, which are liable to confounding, estimation of the causal effect of a drug versus a comparative one is very challenging. This article focuses on methodological issues of importance in designing and analyzing studies to evaluate the safety of marketed drugs, especially marketed traditional Chinese medicine (TCM) products. Advantages and limitations of the current designs and analytic methods for postmarketing studies are discussed, and recommendations are given for improving the validity of postmarketing studies in TCM products.

The Effectiveness of Disaster Risk Communication: A Systematic Review of Intervention Studies

PubMed Central

Bradley, Declan T; McFarland, Marie; Clarke, Mike

2014-01-01

Introduction: A disaster is a serious disruption to the functioning of a community that exceeds its capacity to cope within its own resources. Risk communication in disasters aims to prevent and mitigate harm from disasters, prepare the population before a disaster, disseminate information during disasters and aid subsequent recovery. The aim of this systematic review is to identify, appraise and synthesise the findings of studies of the effects of risk communication interventions during four stages of the disaster cycle. Methods: We searched the Cochrane Central Register of Controlled Trials, Embase, MEDLINE, PsycInfo, Sociological Abstracts, Web of Science and grey literature sources for randomised trials, cluster randomised trials, controlled and uncontrolled before and after studies, interrupted time series studies and qualitative studies of any method of disaster risk communication to at-risk populations. Outcome criteria were disaster-related knowledge and behaviour, and health outcomes. Results: Searches yielded 5,224 unique articles, of which 100 were judged to be potentially relevant. Twenty-five studies met the inclusion criteria, and two additional studies were identified from other searching. The studies evaluated interventions in all four stages of the disaster cycle, included a variety of man-made, natural and infectious disease disasters, and were conducted in many disparate settings. Only one randomised trial and one cluster randomised trial were identified, with less robust designs used in the other studies. Several studies reported improvements in disaster-related knowledge and behaviour. Discussion: We identified and appraised intervention studies of disaster risk communication and present an overview of the contemporary literature. Most studies used non-randomised designs that make interpretation challenging. We do not make specific recommendations for practice but highlight the need for high-quality randomised trials and appropriately-analysed cluster randomised trials in the field of disaster risk communication where these can be conducted within an appropriate research ethics framework. PMID:25642365

Social network recruitment for Yo Puedo: an innovative sexual health intervention in an underserved urban neighborhood—sample and design implications.

PubMed

Minnis, Alexandra M; vanDommelen-Gonzalez, Evan; Luecke, Ellen; Cheng, Helen; Dow, William; Bautista-Arredondo, Sergio; Padian, Nancy S

2015-02-01

Most existing evidence-based sexual health interventions focus on individual-level behavior, even though there is substantial evidence that highlights the influential role of social environments in shaping adolescents' behaviors and reproductive health outcomes. We developed Yo Puedo, a combined conditional cash transfer and life skills intervention for youth to promote educational attainment, job training, and reproductive health wellness that we then evaluated for feasibility among 162 youth aged 16-21 years in a predominantly Latino community in San Francisco, CA. The intervention targeted youth's social networks and involved recruitment and randomization of small social network clusters. In this paper we describe the design of the feasibility study and report participants' baseline characteristics. Furthermore, we examined the sample and design implications of recruiting social network clusters as the unit of randomization. Baseline data provide evidence that we successfully enrolled high risk youth using a social network recruitment approach in community and school-based settings. Nearly all participants (95%) were high risk for adverse educational and reproductive health outcomes based on multiple measures of low socioeconomic status (81%) and/or reported high risk behaviors (e.g., gang affiliation, past pregnancy, recent unprotected sex, frequent substance use; 62%). We achieved variability in the study sample through heterogeneity in recruitment of the index participants, whereas the individuals within the small social networks of close friends demonstrated substantial homogeneity across sociodemographic and risk profile characteristics. Social networks recruitment was feasible and yielded a sample of high risk youth willing to enroll in a randomized study to evaluate a novel sexual health intervention.

Qigong Sensory Training Pilot Study: A Tactile Home Program for Children with or At-Risk for Autism

ERIC Educational Resources Information Center

Tal-Atzili, Orit; Salls, Joyce

2017-01-01

This pilot study investigated the efficacy of Qigong Sensory Training, a parent-implemented tactile intervention, in improving sensory processing and self-regulation in children with or at-risk for autism who were enrolled in early intervention. A pretest-posttest, single-subject design was implemented with three families. After 5 months, atypical…

Group Contingencies to Increase School and Project Attendance in At-Risk Adolescents: A Pilot Study

ERIC Educational Resources Information Center

Costello, Karen M.; Smyth, Sinéad

2017-01-01

The current study employed a group contingency in order to increase school and project attendance in a group of 10 at-risk male adolescents. The participants were already attending a youth diversion project designed to reduce criminal and antisocial behaviors. The group contingency was based on the fantasy football model (an interactive, virtual…

Late Talkers: A Population-Based Study of Risk Factors and School Readiness Consequences

ERIC Educational Resources Information Center

Hammer, Carol Scheffner; Morgan, Paul; Farkas, George; Hillemeier, Marianne; Bitetti, Dana; Maczuga, Steve

2017-01-01

Purpose: This study was designed to (a) identify sociodemographic, pregnancy and birth, family health, and parenting and child care risk factors for being a late talker at 24 months of age; (b) determine whether late talkers continue to have low vocabulary at 48 months; and (c) investigate whether being a late talker plays a unique role in…

Paternal Depression and Risk for Child Neglect in Father-Involved Families of Young Children

ERIC Educational Resources Information Center

Lee, Shawna J.; Taylor, Catherine A.; Bellamy, Jennifer L.

2012-01-01

Objective: To examine the association of paternal depression with risk for parental neglect of young children. Study design: The sample was derived from a birth cohort study of 1,089 families in which both biological parents resided in the home when the target child was 3- and 5-years old. Prospective analyses examined the contribution of paternal…

Self-Efficacy, Risk-Taking Behavior and Mental Health as Predictors of Personal Growth Initiative among University Undergraduates

ERIC Educational Resources Information Center

Ogunyemi, Ajibola O.; Mabekoje, Sesan Ola

2007-01-01

Introduction: This study sought to determine the combined and relative efficacy of self-efficacy, risk-taking behaviour and mental health on personal growth initiative of university undergraduates. Method: The expo-facto research design was used to conduct the study. Stratified random sampling technique was used to select 425 participants from 6…

Literacy Teaching and Learning in Two Kindergarten Classrooms in a School Labeled At-Risk.

ERIC Educational Resources Information Center

Barone, Diane

2002-01-01

Used multiple case-study design in year-long study to assess literacy teaching and learning in two half-day kindergartens at an at-risk school. Found that literacy teaching most often centered on letter recognition and sound/symbol relationships, with few opportunities for children to engage in meaningful dialogue centered on books. Four of 11…

Learning to Appreciate At-Risk Students: Challenging the Beliefs and Attitudes of Teachers and Administrators

ERIC Educational Resources Information Center

Calabrese, Raymond L.; Hummel, Crystal; San Martin, Teresa

2007-01-01

Purpose: The purpose of this paper is to examine the issue of at-risk students in a rural district in Midwestern USA. Design/methodology/approach: This field-based research study used a qualitative embedded case study of a middle and high school informed by an appreciative inquiry theoretical research perspective to identify a positive core of…

Motor Development in Children at Risk of Autism: A Follow-Up Study of Infant Siblings

ERIC Educational Resources Information Center

Leonard, Hayley C.; Bedford, Rachael; Charman, Tony; Elsabbagh, Mayada; Johnson, Mark H.; Hill, Elisabeth L.

2014-01-01

Recently, evidence of poor or atypical motor skills in autism spectrum disorder has led some to argue that motor impairment is a core feature of the condition. The current study uses a longitudinal prospective design to assess the development of motor skills of 20 children at increased risk of developing autism spectrum disorder, who were…

Pilot Study of a Computer-Based Parental Questionnaire and Visual Profile of Obesity Risk in Healthy Preschoolers.

PubMed

Davies, Marilyn A; Terhorst, Lauren; Zhang, Peng; Nakonechny, Amanda J; Nowalk, Mary Patricia

2015-01-01

This group field-tested a computer-based, parental questionnaire entitled the Childhood Obesity Risk Questionnaire 2-5 (CORQ 2-5) designed to assess obesity risk in healthy preschoolers. COR 2-5 generates a profile of seven obesity risk factors. Field studies provided good internal reliability data and evidence of discriminant validity for the CORQ 2-5. Pediatric nurse clinicians found the CORQ 2-5 profile to be clinically relevant. The CORQ 2-5 is a promising measure of obesity risk in preschoolers who attend community-based health centers for their wellchild visits and who are not yet obese. CORQ 2-5 is intended to guide provider-parental obesity risk discussions. Copyright © 2015 Elsevier Inc. All rights reserved.

Effects of Outlets on Cracking Risk and Integral Stability of Super-High Arch Dams

PubMed Central

Hu, Hang

2014-01-01

In this paper, case study on outlet cracking is first conducted for the Goupitan and Xiaowan arch dams. A nonlinear FEM method is then implemented to study effects of the outlets on integral stability of the Xiluodu arch dam under two loading conditions, i.e., normal loading and overloading conditions. On the basis of the case study and the numerical modelling, the outlet cracking mechanism, risk, and corresponding reinforcement measures are discussed. Furthermore, the numerical simulation reveals that (1) under the normal loading conditions, the optimal distribution of the outlets will contribute to the tensile stress release in the local zone of the dam stream surface and decrease the outlet cracking risk during the operation period. (2) Under the overloading conditions, the cracks initiate around the outlets, then propagate along the horizontal direction, and finally coalesce with those in adjacent outlets, where the yield zone of the dam has a shape of butterfly. Throughout this study, a dam outlet cracking risk control and reinforcement principle is proposed to optimize the outlet design, select the appropriate concrete material, strengthen the temperature control during construction period, design reasonable impounding scheme, and repair the cracks according to their classification. PMID:25152907

Patient positioning and ventilator-associated pneumonia.

PubMed

Hess, Dean R

2005-07-01

Rotational beds, prone position, and semi-recumbent position have been proposed as procedures to prevent ventilator-associated pneumonia (VAP). Rotational therapy uses a special bed designed to turn continuously, or nearly continuously, the patient from side to side; specific designs include kinetic therapy and continuous lateral rotation therapy. A meta-analysis of studies evaluating the effect of rotational bed therapy shows a decrease in the risk of pneumonia but no effect on mortality. Two studies reported a lower risk of VAP in patients placed in a prone position, with no effect on mortality. Studies using radiolabeled enteral feeding solutions in mechanically ventilated patients have reported that aspiration of gastric contents occurs to a greater degree when patients are in the supine position, compared with the semirecumbent position. One study reported a lower rate of VAP in patients randomized to semi-recumbent compared to supine position. Although each of the techniques discussed in this paper has been shown to reduce the risk of VAP, none has been shown to affect mortality. The available evidence suggests that semi-recumbent position should be used routinely, rotational therapy should be considered in selected patients, and prone position should not be used as a technique to reduce the risk of VAP.

Kā-HOLO Project: a protocol for a randomized controlled trial of a native cultural dance program for cardiovascular disease prevention in Native Hawaiians.

PubMed

Kaholokula, Joseph Keawe'aimoku; Look, Mele A; Wills, Thomas A; de Silva, Māpuana; Mabellos, Tricia; Seto, Todd B; Ahn, Hyeong Jun; Sinclair, Ka'imi A; Buchwald, Dedra

2017-04-17

As a major risk factor for cardiovascular and cerebrovascular disease (CVD), hypertension affects 33% of U.S. adults. Relative to other US races and ethnicities, Native Hawaiians have a high prevalence of hypertension and are 3 to 4 times more likely to have CVD. Effective, culturally-relevant interventions are needed to address CVD risk in this population. Investigators of the Kā-HOLO Project developed a study design to test the efficacy of an intervention that uses hula, a traditional Hawaiian dance, to increase physical activity and reduce CVD risk. A 2-arm randomized controlled trial with a wait-list control design will be implemented to test a 6-month intervention based on hula to manage blood pressure and reduce CVD risk in 250 adult Native Hawaiians with diagnosed hypertension. Half of the sample will be randomized to each arm, stratified across multiple study sites. Primary outcomes are reduction in systolic blood pressure and improvement in CVD risk as measured by the Framingham Risk Score. Other psychosocial and sociocultural measures will be included to determine mediators of intervention effects on primary outcomes. Assessments will be conducted at baseline, 3 months, and 6 months for all participants, and at 12 months for intervention participants only. This trial will elucidate the efficacy of a novel hypertension management program designed to reduce CVD risk in an indigenous population by using a cultural dance form as its physical activity component. The results of this culturally-based intervention will have implications for other indigenous populations globally and will offer a sustainable, culturally-relevant means of addressing CVD disparities. ClinicalTrials.gov: NCT02620709 , registration date November 23, 2015.

Genetic polymorphisms for estimating risk of atrial fibrillation: a literature-based meta-analysis

PubMed Central

Smith, J. Gustav; Almgren, Peter; Engström, Gunnar; Hedblad, Bo; Platonov, Pyotr G.; Newton-Cheh, Christopher; Melander, Olle

2013-01-01

Objectives Genome-wide association studies have recently identified genetic polymorphisms associated with common, etiologically complex diseases, for which direct-to-consumer genetic testing with provision of absolute genetic risk estimates is marketed by commercial companies. Polymorphisms associated with atrial fibrillation (AF) have shown relatively large risk estimates but the robustness of such estimates across populations and study designs has not been studied. Design A systematic literature review with meta-analysis and assessment of between-study heterogeneity was performed for single nucleotide polymorphisms (SNPs) in the six genetic regions associated with AF in genome-wide or candidate gene studies. Results Data from 18 samples of European ancestry (n=12,100 cases; 115,702 controls) were identified for the SNP on chromosome 4q25 (rs220733), 16 samples (n=12,694 cases; 132,602 controls) for the SNP on 16q22 (rs2106261) and 4 samples (n=5,272 cases; 59,725 controls) for the SNP in KCNH2 (rs1805123). Only the discovery studies were identified for SNPs on 1q21 and in GJA5 and IL6R, why no meta-analyses were performed for those SNPs. In overall random-effects meta-analyses, association with AF was observed for both SNPs from genome-wide studies on 4q25 (OR 1.67, 95% CI=1.50–1.86, p=2×10−21) and 16q22 (OR 1.21, 95% CI=1.13–1.29, p=1×10−8), but not the SNP in KCNH2 from candidate gene studies (p=0.15). There was substantial effect heterogeneity across case-control and cross-sectional studies for both polymorphisms (I2=0.50–0.78, p<0.05), but not across prospective cohort studies (I2=0.39, p=0.15). Both polymorphisms were robustly associated with AF for each study design individually (p<0.05). Conclusions In meta-analyses including up to 150,000 individuals, polymorphisms in two genetic regions were robustly associated with AF across all study designs but with substantial context-dependency of risk estimates. PMID:22690879

Endogeneity in prison risk classification.

PubMed

Shermer, Lauren O'Neill; Bierie, David M; Stock, Amber

2013-10-01

Security designation tools are a key feature of all prisons in the United States, intended as objective measures of risk that funnel inmates into security levels-to prison environments varying in degree of intrusiveness, restriction, dangerousness, and cost. These tools are mostly (if not all) validated by measuring inmates on a set of characteristics, using scores from summations of that information to assign inmates to prisons of varying security level, and then observing whether inmates assumed more risky did in fact offend more. That approach leaves open the possibility of endogeneity--that the harsher prisons are themselves bringing about higher misconduct and thus biasing coefficients assessing individual risk. The current study assesses this potential bias by following an entry cohort of inmates to more than 100 facilities in the Federal Bureau of Prisons (BOP) and exploiting the substantial variation in classification scores within a given prison that derive from systematic overrides of security-level designations for reasons not associated with risk of misconduct. By estimating pooled models of misconduct along with prison-fixed effects specifications, the data show that a portion of the predictive accuracy thought associated with the risk-designation tool used in BOP was a function of facility-level contamination (endogeneity).

Risk of Unwanted Sex for College Women: Evidence for a Red Zone

ERIC Educational Resources Information Center

Kimble, Matthew; Neacsiu, Andrada D.; Flack, William F., Jr.; Horner, Jessica

2008-01-01

Objective: University and college health and counseling centers frequently warn female students about the "red zone"--a period early in a student's first year at college during which she may be at higher risk for unwanted sexual experiences (UWS). The authors designed this study to assess temporal risk for UWS in 1st- and 2nd-year college women.…

Interdependency between Risk Assessments for Self and Other in the Field of Comparative Optimism: The Contribution of Response Times

ERIC Educational Resources Information Center

Spitzenstetter, Florence; Schimchowitsch, Sarah

2012-01-01

By introducing a response-time measure in the field of comparative optimism, this study was designed to explore how people estimate risk to self and others depending on the evaluation order (self/other or other/self). Our results show the interdependency between self and other answers. Indeed, while response time for risk assessment for the self…

V/STOL tilt rotor aircraft study. Volume 1: Conceptual design of useful military and/or commercial aircraft

NASA Technical Reports Server (NTRS)

1972-01-01

The conceptual designs of four useful tilt-rotor aircraft for the 1975 to 1980 time period are presented. Parametric studies leading to design point selection are described, and the characteristics and capabilities of each configuration are presented. An assessment is made of current technology status, and additional tilt-rotor research programs are recommended to minimize the time, cost, and risk of development of these vehicles.

Work and Risk: Perceptions of Nuclear-Power Personnel. a Study in Grounded Theory.

NASA Astrophysics Data System (ADS)

Fields, Claire Dewitt

1992-01-01

The utility industry has devoted time and money to assure personnel within nuclear power plants are informed about occupational risks. Radiation-protection training programs are designed to present information to employees about occupational radiation and protective procedures. Work -related concerns are known to create stress, affect the morale of the workforce, influence collective bargaining, and increase compensation claims. This study was designed to determine perceptions of risk among employees of nuclear power plants and identify variables that influence these perceptions. Four power plants were included in the study, one in Canada and three in the United States. Data were generated through participant observations and interviews of 350 participants during a period of 3 weeks at each plant. Data were gathered and analyzed following procedures advanced by Grounded Theory, a naturalistic methodology used in this study. Training content, information, and communication materials were additional sources of data. Findings indicated employees believed health and safety risks existed within the work environment. Perceptions of risk were influenced by training quality, the work environment, nuclear myths and images of the general public, and fears of family members. Among the three groups of workers, administration personnel, security personnel, and radiation workers, the latter identified a larger number of risks. Workers perceived radiation risks, shift work, and steam pipe ruptures as high-level concerns. Experiencing stress, making mistakes, and fear of sabotage were concerns shared among all employee groups at various levels of concern. Strategies developed by employees were used to control risk. Strategies included teamwork, humor, monitoring, avoidance, reframing, and activism. When risks were perceived as uncontrollable, the employee left the plant. A coping strategy of transferring concerns about radiological risks to nonradiological risks were uncovered in the data. Implications and recommendations include (a) the development of interactive training sessions concerning perceptions and facts of radiological exposures, (b) informational training for nonradiological employees, and (c) educational material development for family members and friends of employees.

Managing Space Radiation Risks on Lunar and Mars Missions: Risk Assessment and Mitigation

NASA Technical Reports Server (NTRS)

Cucinotta, F. A.; George, K.; Hu, X.; Kim, M. H.; Nikjoo, H.

2006-01-01

Radiation-induced health risks are a primary concern for human exploration outside the Earth's magnetosphere, and require improved approaches to risk estimation and tools for mitigation including shielding and biological countermeasures. Solar proton events are the major concern for short-term lunar missions (<60 d), and for long-term missions (>60 d) such as Mars exploration, the exposures to the high energy and charge (HZE) ions that make-up the galactic cosmic rays are the major concern. Health risks from radiation exposure are chronic risks including carcinogenesis and degenerative tissue risks, central nervous system effects, and acute risk such as radiation sickness or early lethality. The current estimate is that a more than four-fold uncertainty exists in the projection of lifetime mortality risk from cosmic rays, which severely limits analysis of possible benefits of shielding or biological countermeasure designs. Uncertainties in risk projections are largely due to insufficient knowledge of HZE ion radiobiology, which has led NASA to develop a unique probabilistic approach to radiation protection. We review NASA's approach to radiation risk assessment including its impact on astronaut dose limits and application of the ALARA (As Low as Reasonably Achievable) principle. The recently opened NASA Space Radiation Laboratory (NSRL) provides the capability to simulate the cosmic rays in controlled ground-based experiments with biological and shielding models. We discuss how research at NSRL will lead to reductions in the uncertainties in risk projection models. In developing mission designs, the reduction of health risks and mission constraints including costs are competing concerns that need to be addressed through optimization procedures. Mitigating the risks from space radiation is a multi-factorial problem involving individual factors (age, gender, genetic makeup, and exposure history), operational factors (planetary destination, mission length, and period in the solar cycle), and shielding characteristics (materials, mass, and topology). We review optimization metrics for radiation protection including scenarios that integrate biophysics models of radiation risks, operational variables, and shielding design tools needed to assess exploration mission designs. We discuss the application of a crosscutting metric, based on probabilistic risk assessment, to lunar and Mars mission trade studies including the assessment of multi-factorial problems and the potential benefits of new radiation health research strategies or mitigation technologies.

Managing Space Radiation Risks On Lunar and Mars Missions: Risk Assessment and Mitigation

NASA Technical Reports Server (NTRS)

Cucinotta, F. A.; George, K.; Hu, X.; Kim, M. H.; Nikjoo, H.

2005-01-01

Radiation-induced health risks are a primary concern for human exploration outside the Earth's magnetosphere, and require improved approaches to risk estimation and tools for mitigation including shielding and biological countermeasures. Solar proton events are the major concern for short-term lunar missions (<60 d), and for long-term missions (>60 d) such as Mars exploration, the exposures to the high energy and charge (HZE) ions that make-up the galactic cosmic rays are the major concern. Health risks from radiation exposure are chronic risks including carcinogenesis and degenerative tissue risks, central nervous system effects, and acute risk such as radiation sickness or early lethality. The current estimate is that a more than four-fold uncertainty exists in the projection of lifetime mortality risk from cosmic rays, which severely limits analysis of possible benefits of shielding or biological countermeasure designs. Uncertainties in risk projections are largely due to insufficient knowledge of HZE ion radiobiology, which has led NASA to develop a unique probabilistic approach to radiation protection. We review NASA's approach to radiation risk assessment including its impact on astronaut dose limits and application of the ALARA (As Low as Reasonably Achievable) principle. The recently opened NASA Space Radiation Laboratory (NSRL) provides the capability to simulate the cosmic rays in controlled ground-based experiments with biological and shielding models. We discuss how research at NSRL will lead to reductions in the uncertainties in risk projection models. In developing mission designs, the reduction of health risks and mission constraints including costs are competing concerns that need to be addressed through optimization procedures. Mitigating the risks from space radiation is a multi-factorial problem involving individual factors (age, gender, genetic makeup, and exposure history), operational factors (planetary destination, mission length, and period in the solar cycle), and shielding characteristics (materials, mass, and topology). We review optimization metrics for radiation protection including scenarios that integrate biophysics models of radiation risks, operational variables, and shielding design tools needed to assess exploration mission designs. We discuss the application of a crosscutting metric, based on probabilistic risk assessment, to lunar and Mars mission trade studies including the assessment of multi-factorial problems and the potential benefits of new radiation health research strategies or mitigation technologies.

Managing Space Radiation Risks on Lunar and Mars Missions: Risk Assessment and Mitigation

NASA Technical Reports Server (NTRS)

Cucinotta, F. A.; George, K.; Hu, X.; Kim, M. H.; Nikjoo, H.; Ponomarev, A.; Ren, L.; Shavers, M. R.; Wu, H.

2005-01-01

Radiation-induced health risks are a primary concern for human exploration outside the Earth's magnetosphere, and require improved approaches to risk estimation and tools for mitigation including shielding and biological countermeasures. Solar proton events are the major concern for short-term lunar missions (<60 d), and for long-term missions (>60 d) such as Mars exploration, the exposures to the high energy and charge (HZE) ions that make-up the galactic cosmic rays are the major concern. Health risks from radiation exposure are chronic risks including carcinogenesis and degenerative tissue risks, central nervous system effects, and acute risk such as radiation sickness or early lethality. The current estimate is that a more than four-fold uncertainty exists in the projection of lifetime mortality risk from cosmic rays, which severely limits analysis of possible benefits of shielding or biological countermeasure designs. Uncertainties in risk projections are largely due to insufficient knowledge of HZE ion radiobiology, which has led NASA to develop a unique probabilistic approach to radiation protection. We review NASA's approach to radiation risk assessment including its impact on astronaut dose limits and application of the ALARA (As Low as Reasonably Achievable) principle. The recently opened NASA Space Radiation Laboratory (NSRL) provides the capability to simulate the cosmic rays in controlled ground-based experiments with biological and shielding models. We discuss how research at NSRL will lead to reductions in the uncertainties in risk projection models. In developing mission designs, the reduction of health risks and mission constraints including costs are competing concerns that need to be addressed through optimization procedures. Mitigating the risks from space radiation is a multi-factorial problem involving individual factors (age, gender, genetic makeup, and exposure history), operational factors (planetary destination, mission length, and period in the solar cycle), and shielding characteristics (materials, mass, and topology). We review optimization metrics for radiation protection including scenarios that integrate biophysics models of radiation risks, operational variables, and shielding design tools needed to assess exploration mission designs. We discuss the application of a crosscutting metric, based on probabilistic risk assessment, to lunar and Mars mission trade studies including the assessment of multi-factorial problems and the potential benefits of new radiation health research strategies or mitigation technologies.

Flood Catastrophe Model for Designing Optimal Flood Insurance Program: Estimating Location-Specific Premiums in the Netherlands.

PubMed

Ermolieva, T; Filatova, T; Ermoliev, Y; Obersteiner, M; de Bruijn, K M; Jeuken, A

2017-01-01

As flood risks grow worldwide, a well-designed insurance program engaging various stakeholders becomes a vital instrument in flood risk management. The main challenge concerns the applicability of standard approaches for calculating insurance premiums of rare catastrophic losses. This article focuses on the design of a flood-loss-sharing program involving private insurance based on location-specific exposures. The analysis is guided by a developed integrated catastrophe risk management (ICRM) model consisting of a GIS-based flood model and a stochastic optimization procedure with respect to location-specific risk exposures. To achieve the stability and robustness of the program towards floods with various recurrences, the ICRM uses stochastic optimization procedure, which relies on quantile-related risk functions of a systemic insolvency involving overpayments and underpayments of the stakeholders. Two alternative ways of calculating insurance premiums are compared: the robust derived with the ICRM and the traditional average annual loss approach. The applicability of the proposed model is illustrated in a case study of a Rotterdam area outside the main flood protection system in the Netherlands. Our numerical experiments demonstrate essential advantages of the robust premiums, namely, that they: (1) guarantee the program's solvency under all relevant flood scenarios rather than one average event; (2) establish a tradeoff between the security of the program and the welfare of locations; and (3) decrease the need for other risk transfer and risk reduction measures. © 2016 Society for Risk Analysis.

Risk factors associated with asbestos-related diseases: a community-based case-control study.

PubMed

Rosell-Murphy, Magdalena-Isabel; Abós-Herràndiz, Rafael; Olivella, Josep Tarrés; Alberti-Casas, Constança; Allas, Isabel García; Artés, Xavier Martinez; Günther, Ilona Krier; Malet, Isidre Grimau; Martínez, Ramon Orriols; Canela-Soler, Jaume

2013-08-06

Asbestos is a first level carcinogen. However, few epidemiological studies analyse the risk and protective factors associated with asbestos-related diseases and follow up these conditions in the general population. Pleural mesothelioma, caused by inhalation of asbestos fibres at work, at home or in the environment, is the most representative asbestos-related disease.The objectives of this study are to analyse the risk and protective factors associated with asbestos-related diseases and to investigate the incidence of new clinical manifestations in patients already diagnosed with some form of ARD. We have designed a matched case-control study with follow up of both cohorts from a population of a health district of the Barcelona province that has been exposed to asbestos for a period of 90 years. A better understanding of asbestos-related diseases should improve i) the clinical and epidemiological follow up of patients with this condition; ii) the design of new treatment strategies; iii) and the development of preventive activities. At the end of the study, the two cohorts created in this study (affected cases and healthy controls) will constitute the basis for future research.

Evolving trends in aortic valve replacement: A statewide experience.

PubMed

Kim, Karen M; Shannon, Francis; Paone, Gaetano; Lall, Shelly; Batra, Sanjay; Boeve, Theodore; DeLucia, Alphonse; Patel, Himanshu J; Theurer, Patricia F; He, Chang; Clark, Melissa J; Sultan, Ibrahim; Deeb, George Michael; Prager, Richard L

2018-06-17

Transcatheter aortic valve replacement (TAVR) is an alternative to surgical aortic valve replacement (SAVR) for the treatment of aortic stenosis in patients at intermediate, high, and extreme risk for mortality from SAVR. We examined recent trends in aortic valve replacement (AVR) in Michigan. The Michigan Society of Thoracic and Cardiovascular Surgeons Quality Collaborative (MSTCVS-QC) database was used to determine the number of SAVR and TAVR cases performed from January 2012 through June 2017. Patients were divided into low, intermediate, high, and extreme risk groups based on STS predicted risk of mortality (PROM). TAVR patients in the MSTCVS-QC database were also matched with those in the Transcatheter Valve Therapy Registry to determine their Heart Team-designated risk category. During the study period 9517 SAVR and 4470 TAVR cases were performed. Total annual AVR volume increased by 40.0% (from 2086 to 2920), with a 13.3% decrease in number of SAVR cases (from 1892 to 1640) and a 560% increase in number of TAVR cases (from 194 to 1280). Greater than 90% of SAVR patients had PROM ≤8%. While >70% of TAVR patients had PROM ≤ 8%, they were mostly designated as high or extreme risk by a Heart Team. During the study period, SAVR volume gradually declined and TAVR volume dramatically increased. This was mostly due to a new group of patients with lower STS PROM who were designated as higher risk by a Heart Team due to characteristics not completely captured by the STS PROM score. © 2018 Wiley Periodicals, Inc.

Risk Informed Design as Part of the Systems Engineering Process

NASA Technical Reports Server (NTRS)

Deckert, George

2010-01-01

This slide presentation reviews the importance of Risk Informed Design (RID) as an important feature of the systems engineering process. RID is based on the principle that risk is a design commodity such as mass, volume, cost or power. It also reviews Probabilistic Risk Assessment (PRA) as it is used in the product life cycle in the development of NASA's Constellation Program.

A Responsive Cyber Risk Ecosystem

DTIC Science & Technology

2017-01-19

UNCLASSIFIED - Distribution A: Approved for public release; distribution unlimited AIR FORCE CYBERWORX REPORT 16-003: A RESPONSIVE CYBER RISK...right problem to solve and find meaningful solutions by exploring a wide range of possible answers to the design problem. For the Responsive Cyber ...Risk Dashboard Design Project, CyberWorx brought together a design team of 25 participants from UASFA and Industry to explore how cyber risk to AF

Trade Studies of Space Launch Architectures using Modular Probabilistic Risk Analysis

NASA Technical Reports Server (NTRS)

Mathias, Donovan L.; Go, Susie

2006-01-01

A top-down risk assessment in the early phases of space exploration architecture development can provide understanding and intuition of the potential risks associated with new designs and technologies. In this approach, risk analysts draw from their past experience and the heritage of similar existing systems as a source for reliability data. This top-down approach captures the complex interactions of the risk driving parts of the integrated system without requiring detailed knowledge of the parts themselves, which is often unavailable in the early design stages. Traditional probabilistic risk analysis (PRA) technologies, however, suffer several drawbacks that limit their timely application to complex technology development programs. The most restrictive of these is a dependence on static planning scenarios, expressed through fault and event trees. Fault trees incorporating comprehensive mission scenarios are routinely constructed for complex space systems, and several commercial software products are available for evaluating fault statistics. These static representations cannot capture the dynamic behavior of system failures without substantial modification of the initial tree. Consequently, the development of dynamic models using fault tree analysis has been an active area of research in recent years. This paper discusses the implementation and demonstration of dynamic, modular scenario modeling for integration of subsystem fault evaluation modules using the Space Architecture Failure Evaluation (SAFE) tool. SAFE is a C++ code that was originally developed to support NASA s Space Launch Initiative. It provides a flexible framework for system architecture definition and trade studies. SAFE supports extensible modeling of dynamic, time-dependent risk drivers of the system and functions at the level of fidelity for which design and failure data exists. The approach is scalable, allowing inclusion of additional information as detailed data becomes available. The tool performs a Monte Carlo analysis to provide statistical estimates. Example results of an architecture system reliability study are summarized for an exploration system concept using heritage data from liquid-fueled expendable Saturn V/Apollo launch vehicles.

Design-corrected variation by centre in mortality reduction in the ERSPC randomised prostate cancer screening trial.

PubMed

Hakama, Matti; Moss, Sue M; Stenman, Ulf-Hakan; Roobol, Monique J; Zappa, Marco; Carlsson, Sigrid; Randazzo, Marco; Nelen, Vera; Hugosson, Jonas

2017-06-01

Objectives To calculate design-corrected estimates of the effect of screening on prostate cancer mortality by centre in the European Randomised Study of Screening for Prostate Cancer (ERSPC). Setting The ERSPC has shown a 21% reduction in prostate cancer mortality in men invited to screening with follow-up truncated at 13 years. Centres either used pre-consent randomisation (effectiveness design) or post-consent randomisation (efficacy design). Methods In six centres (three effectiveness design, three efficacy design) with follow-up until the end of 2010, or maximum 13 years, the effect of screening was estimated as both effectiveness (mortality reduction in the target population) and efficacy (reduction in those actually screened). Results The overall crude prostate cancer mortality risk ratio in the intervention arm vs control arm for the six centres was 0.79 ranging from a 14% increase to a 38% reduction. The risk ratio was 0.85 in centres with effectiveness design and 0.73 in those with efficacy design. After correcting for design, overall efficacy was 27%, 24% in pre-consent and 29% in post-consent centres, ranging between a 12% increase and a 52% reduction. Conclusion The estimated overall effect of screening in attenders (efficacy) was a 27% reduction in prostate cancer mortality at 13 years' follow-up. The variation in efficacy between centres was greater than the range in risk ratio without correction for design. The centre-specific variation in the mortality reduction could not be accounted for by the randomisation method.

The Proof of the Pudding?: A Case Study of an "At-Risk" Design-Based Inquiry Science Curriculum

ERIC Educational Resources Information Center

Chue, Shien; Lee, Yew-Jin

2013-01-01

When students collaboratively design and build artifacts that require relevant understanding and application of science, many aspects of scientific literacy are developed. Design-based inquiry (DBI) is one such pedagogy that can serve these desired goals of science education well. Focusing on a Projectile Science curriculum previously found to be…

Assessment Design and Cheating Risk in Online Instruction

ERIC Educational Resources Information Center

Harmon, Oskar R.; Lambrinos, James; Buffolino, Judy

2010-01-01

Many consider online courses to be an inferior alternative to traditional face-to-face (f2f) courses because exam cheating is thought to occur more often in online courses. This study examines how the assessment design in online courses contributes to this perception. Following a literature review, the assessment design in a sample of online…

Chronic disease risk factors among hotel workers

PubMed Central

Gawde, Nilesh Chandrakant; Kurlikar, Prashika R.

2016-01-01

Context: Non-communicable diseases have emerged as a global health issue. Role of occupation in pathogenesis of non-communicable diseases has not been explored much especially in the hospitality industry. Aims: Objectives of this study include finding risk factor prevalence among hotel workers and studying relationship between occupational group and chronic disease risk factors chiefly high body mass index. Settings and Design: A cross-sectional study was conducted among non-managerial employees from classified hotels in India. Materials and Methods: The study participants self-administered pre-designed pilot-tested questionnaires. Statistical analysis used: The risk factor prevalence rates were expressed as percentages. Chi-square test was used for bi-variate analysis. Overweight was chosen as ‘outcome’ variable of interest and binary multi-logistic regression analysis was used to identify determinants. Results: The prevalence rates of tobacco use, alcohol use, inadequate physical activity and inadequate intake of fruits and vegetables were 32%, 49%, 24% and 92% respectively among hotel employees. Tobacco use was significantly common among those in food preparation and service, alcohol use among those in food service and security and leisure time physical activity among front office workers. More than two-fifths (42.7%) were overweight. Among the hotel workers, those employed in food preparation and security had higher odds of 1.650 (CI: 1.025 – 2.655) and 3.245 (CI: 1.296 – 8.129) respectively of being overweight. Conclusions: Prevalence of chronic disease risk factors is high among hotel workers. Risk of overweight is significantly high in food preparation and security departments and workplace interventions are necessary to address these risks PMID:27390474

The Cardiovascular Intervention Improvement Telemedicine Study (CITIES): Rationale for a Tailored Behavioral and Educational Pharmacist-Administered Intervention for Achieving Cardiovascular Disease Risk Reduction

PubMed Central

Zullig, Leah L.; Melnyk, S. Dee; Stechuchak, Karen M.; McCant, Felicia; Danus, Susanne; Oddone, Eugene; Bastian, Lori; Olsen, Maren; Edelman, David; Rakley, Susan; Morey, Miriam

2014-01-01

Abstract Background: Hypertension, hyperlipidemia, and diabetes are significant, but often preventable, contributors to cardiovascular disease (CVD) risk. Medication and behavioral nonadherence are significant barriers to successful hypertension, hyperlidemia, and diabetes management. Our objective was to describe the theoretical framework underlying a tailored behavioral and educational pharmacist-administered intervention for achieving CVD risk reduction. Materials and Methods: Adults with poorly controlled hypertension and/or hyperlipidemia were enrolled from three outpatient primary care clinics associated with the Durham Veterans Affairs Medical Center (Durham, NC). Participants were randomly assigned to receive a pharmacist-administered, tailored, 1-year telephone-based intervention or usual care. The goal of the study was to reduce the risk for CVD through a theory-driven intervention to increase medication adherence and improve health behaviors. Results: Enrollment began in November 2011 and is ongoing. The target sample size is 500 patients. Conclusions: The Cardiovascular Intervention Improvement Telemedicine Study (CITIES) intervention has been designed with a strong theoretical underpinning. The theoretical foundation and intervention are designed to encourage patients with multiple comorbidities and poorly controlled CVD risk factors to engage in home-based monitoring and tailored telephone-based interventions. Evidence suggests that clinical pharmacist-administered telephone-based interventions may be efficiently integrated into primary care for patients with poorly controlled CVD risk factors. PMID:24303930

Case-control study on uveal melanoma (RIFA): rational and design

PubMed Central

Schmidt-Pokrzywniak, Andrea; Jöckel, Karl-Heinz; Bornfeld, Norbert; Stang, Andreas

2004-01-01

Background Although a rare disease, uveal melanoma is the most common primary intraocular malignancy in adults, with an incidence rate of up to 1.0 per 100,000 persons per year in Europe. Only a few consistent risk factors have been identified for this disease. We present the study design of an ongoing incident case-control study on uveal melanoma (acronym: RIFA study) that focuses on radiofrequency radiation as transmitted by radio sets and wireless telephones, occupational risk factors, phenotypical characteristics, and UV radiation. Methods/Design We conduct a case-control study to identify the role of different exposures in the development of uveal melanoma. The cases of uveal melanoma were identified at the Division of Ophthalmology, University of Essen, a referral centre for tumours of the eye. We recruit three control groups: population controls, controls sampled from those ophthalmologists who referred cases to the Division of Ophthalmology, University of Duisburg-Essen, and sibling controls. For each case the controls are matched on sex and age (five year groups), except for sibling controls. The data are collected from the study participants by short self-administered questionnaire and by telephone interview. During and at the end of the field phase, the data are quality-checked. To estimate the effect of exposures on uveal melanoma risk, we will use conditional logistic regression that accounts for the matching factors and allows to control for potential confounding. PMID:15318944

Collaborative Design

ERIC Educational Resources Information Center

Broderick, Debora

2014-01-01

This practitioner research study investigates the power of multimodal texts within a real-world context and argues that a participatory culture focused on literary arts offers marginalized high school students opportunities for collaborative design and authoring. Additionally, this article invites educators to rethink the at-risk label. This…

Columbus safety and reliability

NASA Astrophysics Data System (ADS)

Longhurst, F.; Wessels, H.

1988-10-01

Analyses carried out to ensure Columbus reliability, availability, and maintainability, and operational and design safety are summarized. Failure modes/effects/criticality is the main qualitative tool used. The main aspects studied are fault tolerance, hazard consequence control, risk minimization, human error effects, restorability, and safe-life design.

ROBIS: A new tool to assess risk of bias in systematic reviews was developed.

PubMed

Whiting, Penny; Savović, Jelena; Higgins, Julian P T; Caldwell, Deborah M; Reeves, Barnaby C; Shea, Beverley; Davies, Philippa; Kleijnen, Jos; Churchill, Rachel

2016-01-01

To develop ROBIS, a new tool for assessing the risk of bias in systematic reviews (rather than in primary studies). We used four-stage approach to develop ROBIS: define the scope, review the evidence base, hold a face-to-face meeting, and refine the tool through piloting. ROBIS is currently aimed at four broad categories of reviews mainly within health care settings: interventions, diagnosis, prognosis, and etiology. The target audience of ROBIS is primarily guideline developers, authors of overviews of systematic reviews ("reviews of reviews"), and review authors who might want to assess or avoid risk of bias in their reviews. The tool is completed in three phases: (1) assess relevance (optional), (2) identify concerns with the review process, and (3) judge risk of bias. Phase 2 covers four domains through which bias may be introduced into a systematic review: study eligibility criteria; identification and selection of studies; data collection and study appraisal; and synthesis and findings. Phase 3 assesses the overall risk of bias in the interpretation of review findings and whether this considered limitations identified in any of the phase 2 domains. Signaling questions are included to help judge concerns with the review process (phase 2) and the overall risk of bias in the review (phase 3); these questions flag aspects of review design related to the potential for bias and aim to help assessors judge risk of bias in the review process, results, and conclusions. ROBIS is the first rigorously developed tool designed specifically to assess the risk of bias in systematic reviews. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

Applying a weed risk assessment approach to GM crops.

PubMed

Keese, Paul K; Robold, Andrea V; Myers, Ruth C; Weisman, Sarah; Smith, Joe

2014-12-01

Current approaches to environmental risk assessment of genetically modified (GM) plants are modelled on chemical risk assessment methods, which have a strong focus on toxicity. There are additional types of harms posed by plants that have been extensively studied by weed scientists and incorporated into weed risk assessment methods. Weed risk assessment uses robust, validated methods that are widely applied to regulatory decision-making about potentially problematic plants. They are designed to encompass a broad variety of plant forms and traits in different environments, and can provide reliable conclusions even with limited data. The knowledge and experience that underpin weed risk assessment can be harnessed for environmental risk assessment of GM plants. A case study illustrates the application of the Australian post-border weed risk assessment approach to a representative GM plant. This approach is a valuable tool to identify potential risks from GM plants.

Diagnostic accuracy of different caries risk assessment methods. A systematic review.

PubMed

Senneby, Anna; Mejàre, Ingegerd; Sahlin, Nils-Eric; Svensäter, Gunnel; Rohlin, Madeleine

2015-12-01

To evaluate the accuracy of different methods used to identify individuals with increased risk of developing dental coronal caries. Studies on following methods were included: previous caries experience, tests using microbiota, buffering capacity, salivary flow rate, oral hygiene, dietary habits and sociodemographic variables. QUADAS-2 was used to assess risk of bias. Sensitivity, specificity, predictive values, and likelihood ratios (LR) were calculated. Quality of evidence based on ≥3 studies of a method was rated according to GRADE. PubMed, Cochrane Library, Web of Science and reference lists of included publications were searched up to January 2015. From 5776 identified articles, 18 were included. Assessment of study quality identified methodological limitations concerning study design, test technology and reporting. No study presented low risk of bias in all domains. Three or more studies were found only for previous caries experience and salivary mutans streptococci and quality of evidence for these methods was low. Evidence regarding other methods was lacking. For previous caries experience, sensitivity ranged between 0.21 and 0.94 and specificity between 0.20 and 1. Tests using salivary mutans streptococci resulted in low sensitivity and high specificity. For children with primary teeth at baseline, pooled LR for a positive test was 3 for previous caries experience and 4 for salivary mutans streptococci, given a threshold ≥10(5) CFU/ml. Evidence on the validity of analysed methods used for caries risk assessment is limited. As methodological quality was low, there is a need to improve study design. Low validity for the analysed methods may lead to patients with increased risk not being identified, whereas some are falsely identified as being at risk. As caries risk assessment guides individualized decisions on interventions and intervals for patient recall, improved performance based on best evidence is greatly needed. Copyright © 2015 Elsevier Ltd. All rights reserved.

Does unbelted safety requirement affect protection for belted occupants?

PubMed

Hu, Jingwen; Klinich, Kathleen D; Manary, Miriam A; Flannagan, Carol A C; Narayanaswamy, Prabha; Reed, Matthew P; Andreen, Margaret; Neal, Mark; Lin, Chin-Hsu

2017-05-29

Federal regulations in the United States require vehicles to meet occupant performance requirements with unbelted test dummies. Removing the test requirements with unbelted occupants might encourage the deployment of seat belt interlocks and allow restraint optimization to focus on belted occupants. The objective of this study is to compare the performance of restraint systems optimized for belted-only occupants with those optimized for both belted and unbelted occupants using computer simulations and field crash data analyses. In this study, 2 validated finite element (FE) vehicle/occupant models (a midsize sedan and a midsize SUV) were selected. Restraint design optimizations under standardized crash conditions (U.S.-NCAP and FMVSS 208) with and without unbelted requirements were conducted using Hybrid III (HIII) small female and midsize male anthropomorphic test devices (ATDs) in both vehicles on both driver and right front passenger positions. A total of 10 to 12 design parameters were varied in each optimization using a combination of response surface method (RSM) and genetic algorithm. To evaluate the field performance of restraints optimized with and without unbelted requirements, 55 frontal crash conditions covering a greater variety of crash types than those in the standardized crashes were selected. A total of 1,760 FE simulations were conducted for the field performance evaluation. Frontal crashes in the NASS-CDS database from 2002 to 2012 were used to develop injury risk curves and to provide the baseline performance of current restraint system and estimate the injury risk change by removing the unbelted requirement. Unbelted requirements do not affect the optimal seat belt and airbag design parameters in 3 out of 4 vehicle/occupant position conditions, except for the SUV passenger side. Overall, compared to the optimal designs with unbelted requirements, optimal designs without unbelted requirements generated the same or lower total injury risks for belted occupants depending on statistical methods used for the analysis, but they could also increase the total injury risks for unbelted occupants. This study demonstrated potential for reducing injury risks to belted occupants if the unbelted requirements are eliminated. Further investigations are necessary to confirm these findings.

2014 Space Human Factors Engineering Standing Review Panel

NASA Technical Reports Server (NTRS)

Steinberg, Susan

2014-01-01

The 2014 Space Human Factors Engineering (SHFE) Standing Review Panel (from here on referred to as the SRP) participated in a WebEx/teleconference with members of the Space Human Factors and Habitability (SHFH) Element, representatives from the Human Research Program (HRP), the National Space Biomedical Research Institute (NSBRI), and NASA Headquarters on November 17, 2014 (list of participants is in Section XI of this report). The SRP reviewed the updated research plans for the Risk of Incompatible Vehicle/Habitat Design (HAB Risk) and the Risk of Performance Errors Due to Training Deficiencies (Train Risk). The SRP also received a status update on the Risk of Inadequate Critical Task Design (Task Risk), the Risk of Inadequate Design of Human and Automation/Robotic Integration (HARI Risk), and the Risk of Inadequate Human-Computer Interaction (HCI Risk).

Simplified spacecraft vulnerability assessments at component level in early design phase at the European Space Agency's Concurrent Design Facility

NASA Astrophysics Data System (ADS)

Kempf, Scott; Schäfer, Frank K.; Cardone, Tiziana; Ferreira, Ivo; Gerené, Sam; Destefanis, Roberto; Grassi, Lilith

2016-12-01

During recent years, the state-of-the-art risk assessment of the threat posed to spacecraft by micrometeoroids and space debris has been expanded to the analysis of failure modes of internal spacecraft components. This method can now be used to perform risk analyses for satellites to assess various failure levels - from failure of specific sub-systems to catastrophic break-up. This new assessment methodology is based on triple-wall ballistic limit equations (BLEs), specifically the Schäfer-Ryan-Lambert (SRL) BLE, which is applicable for describing failure threshold levels for satellite components following a hypervelocity impact. The methodology is implemented in the form of the software tool Particle Impact Risk and vulnerability Analysis Tool (PIRAT). During a recent European Space Agency (ESA) funded study, the PIRAT functionality was expanded in order to provide an interface to ESA's Concurrent Design Facility (CDF). The additions include a geometry importer and an OCDT (Open Concurrent Design Tool) interface. The new interface provides both the expanded geometrical flexibility, which is provided by external computer aided design (CAD) modelling, and an ease of import of existing data without the need for extensive preparation of the model. The reduced effort required to perform vulnerability analyses makes it feasible for application during early design phase, at which point modifications to satellite design can be undertaken with relatively little extra effort. The integration of PIRAT in the CDF represents the first time that vulnerability analyses can be performed in-session in ESA's CDF and the first time that comprehensive vulnerability studies can be applied cost-effectively in early design phase in general.

Recreation safety in municipal parks - Bloomington, Indiana and Tsukuba, Japan: a comparison study of risk management

Treesearch

Bruce Hronek

2001-01-01

Cultural differences affects the design and use of playground equipment in parks. Comparative research exploring the differences in playground facilities, parental supervision, and use was conducted on-site in Tsukuba City, Ibaraki Perfecture, Japan and Bloomington, Indiana, USA. The study examines park design, play equipment, sports fields, use patterns, and parental...

Stroke-Related Knowledge, Lifestyle Behaviours and Health Beliefs in Singaporean Chinese: Implications for Health Education

ERIC Educational Resources Information Center

Wong, Wai Pong; Yeung, Meredith; Loh, Susan; Lee, Mina; Ghazali, F.; Chan, C. J.; Feng, S.; Liew, Y. V.; Seah, P. F.; Wee, J.; Wang, J.; Huang, X.; Dean, Elizabeth

2013-01-01

Objective: The objective of the present study was to describe stroke-related knowledge (risk factors, warning signs and emergency response), lifestyle behaviours and health beliefs among Singaporean Chinese, and to identify any factors associated with such knowledge, behaviours and beliefs. Design: This was a cross-sectional study design employing…

Designing a Weight Gain Prevention Trial for Young Adults: The CHOICES Study

ERIC Educational Resources Information Center

Lytle, Leslie A.; Moe, Stacey G.; Nanney, M. Susie; Laska, Melissa N.; Linde, Jennifer A.; Petrich, Christine A.; Sevcik, Sarah M.

2014-01-01

Background: Young adults are at risk for weight gain. Little is known about how to design weight control programs to meet the needs of young adults and few theory-based interventions have been evaluated in a randomized control trial. The Choosing Healthy Options in College Environments and Settings (CHOICES) study was funded to create a…

77 FR 20026 - Draft Guidance for Industry: Modified Risk Tobacco Product Applications; Availability; Agency...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-03

... appropriate scientific and medical experts, on the design and conduct of studies required for the assessment... functions, including the design and conduct of research, the oversight of specific studies, and the... any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft...

Preliminary design study of advanced composite blade and hub and nonmechanical control system for the tilt-rotor aircraft. Volume 1: Engineering studies

NASA Technical Reports Server (NTRS)

Alexander, H. R.; Smith, K. E.; Mcveigh, M. A.; Dixon, P. G.; Mcmanus, B. L.

1979-01-01

Composite structures technology is applied in a preliminary design study of advanced technology blades and hubs for the XV-15 tilt rotor research demonstrator aircraft. Significant improvements in XV-15 hover and cruise performance are available using blades designed for compatibility with the existing aircraft, i.e., blade installation would not require modification of the airframe, hub or upper controls. Provision of a low risk nonmechanical control system was also studied, and a development specification is given.

Orbit transfer vehicle engine study, phase A, extension 1: Volume 2: Study results

NASA Technical Reports Server (NTRS)

Mellish, J. A.

1981-01-01

Because of the advantage of the Advanced Expander Cycle Engine brought out in initial studies, further design optimization and comparative analyses were undertaken. The major results and conclusion derived are summarized. The primary areas covered are (1) thrust chamber geometry optimization, (2) expander cycle optimization, (3) alternate low thrust capability, (4) safety and reliability, (5) development risk comparison, and (6) cost comparisons. All of the results obtained were used to baseline the initial design concept for the OTV Advanced Expander Cycle Engine Point Design Study.

The early development of stereotypy and self-injury: a review of research methods.

PubMed

Symons, F J; Sperry, L A; Dropik, P L; Bodfish, J W

2005-02-01

The origin and developmental course of stereotypic and self-injurious behaviour among individuals with developmental disabilities such as intellectual disability (ID) or pervasive development disorders such as autism is not well understood. Twelve studies designed to document the prevalence, nature, or development of stereotypic and/or self-injurious behaviour in children under 5 years of age and identified as at risk for developmental delay or disability were reviewed. Comparisons were made with similar studies with typically developing children. It appears that the onset of naturally occurring rhythmic motor stereotypies is delayed in young at-risk children, but that the sequencing may be similar. A very small database, differences in samples, measures, and designs limited the degree to which comparisons could be made across studies. Future work is needed based on appropriately designed prospective comparison studies and uniform quantitative measures to provide an empirical basis for new knowledge about the early development of one of the most serious behaviour disorders afflicting children with ID and related problems of development.

Eye injury risk associated with remote control toy helicopter blades.

PubMed

Alphonse, Vanessa D; Kemper, Andrew R; Rowson, Steven; Duma, Stefan M

2012-01-01

Eye injuries can be caused by a variety of consumer products and toys. Recently, indoor remote controlled (RC) toy helicopters have become very popular. The purpose of this study is to quantify eye injury risk associated with five commercially available RC toy helicopter blades. An experimental matrix of 25 tests was developed to test five different RC toy helicopter blades at full battery power on six postmortem human eyes. A pressure sensor inserted through the optic nerve measured intraocular pressure. Corneal abrasion was assessed post-impact using fluorescein dye. Intraocular pressure was correlated to injury risk for hyphema, lens damage, retinal damage, and globe rupture using published risk functions. All tests resulted in corneal abrasions; however, no other injuries were observed. The 25 tests produced an increase intraocular pressure between 15.2 kPa and 99.3 kPa (114.3 mmHg and 744.7 mmHg). Calculated blade velocities ranged between 16.0 m/s and 25.4 m/s. Injury risk for hyphema was a maximum of 0.2%. Injury risk for lens damage, retinal damage, and globe rupture was 0.0% for all tests. Blade design parameters such as length and mass did not affect the risk of eye injury. This is the first study to quantify the risk of eye injury from RC toy helicopter blades. While corneal abrasions were observed, more serious eye injuries were neither observed nor predicted to have occurred. Results from this study are critical for establishing safe design thresholds for RC toy helicopter blades so that more serious injuries can be prevented.

Serum carotenoid and tocopherol concentrations and risk of asthma in childhood: a nested case-control study.

PubMed

Hämäläinen, N; Nwaru, B I; Erlund, I; Takkinen, H-M; Ahonen, S; Toppari, J; Ilonen, J; Veijola, R; Knip, M; Kaila, M; Virtanen, S M

2017-03-01

The antioxidant hypothesis regarding the risk of asthma in childhood has resulted in inconsistent findings. Some data indicate that the role of antioxidants in childhood asthma risk may have a critical time window of effect, but only a well-designed longitudinal cohort study can clarify this hypothesis. To study the longitudinal associations between serum carotenoid and tocopherol concentrations during the first 4 years of life and asthma risk by the age of 5 years. Based on a case-control design nested within a Finnish birth cohort, 146 asthma cases were matched to 270 controls on birth time, sex, genetic risk, and birth place. Non-fasting blood samples were collected at the ages of 1, 1.5, 2, 3, and 4 years and serum carotenoids and tocopherols were analysed. Parents reported the presence and age at start of persistent doctor-diagnosed asthma in the child at the age of 5 years. Data analyses were conducted using generalized estimating equations. We did not find strong associations between serum carotenoids and tocopherols and the risk of asthma based on age-specific and longitudinal analyses. Both lower and higher quarters of α-carotene and γ-tocopherol increased the risk of asthma. The current findings do not support the suggestion that the increased prevalence of asthma may be a consequence of decreased intake of antioxidant nutrients. Moreover, we did not confirm any critical time window of impact of antioxidants on asthma risk. Replication of these findings in similar longitudinal settings will strengthen this evidence base. © 2017 John Wiley & Sons Ltd.

Wind energy development: methods for assessing risks to birds and bats pre-construction

USGS Publications Warehouse

Katzner, Todd E.; Bennett, Victoria; Miller, Tricia A.; Duerr, Adam E.; Braham, Melissa A.; Hale, Amanda

2016-01-01

Wind power generation is rapidly expanding. Although wind power is a low-carbon source of energy, it can impact negatively birds and bats, either directly through fatality or indirectly by displacement or habitat loss. Pre-construction risk assessment at wind facilities within the United States is usually required only on public lands. When conducted, it generally involves a 3-tier process, with each step leading to more detailed and rigorous surveys. Preliminary site assessment (U.S. Fish and Wildlife Service, Tier 1) is usually conducted remotely and involves evaluation of existing databases and published materials. If potentially at-risk wildlife are present and the developer wishes to continue the development process, then on-site surveys are conducted (Tier 2) to verify the presence of those species and to assess site-specific features (e.g., topography, land cover) that may influence risk from turbines. The next step in the process (Tier 3) involves quantitative or scientific studies to assess the potential risk of the proposed project to wildlife. Typical Tier-3 research may involve acoustic, aural, observational, radar, capture, tracking, or modeling studies, all designed to understand details of risk to specific species or groups of species at the given site. Our review highlights several features lacking from many risk assessments, particularly the paucity of before-and-after-control- impact (BACI) studies involving modeling and a lack of understanding of cumulative effects of wind facilities on wildlife. Both are essential to understand effective designs for pre-construction monitoring and both would help expand risk assessment beyond eagles.

Occupational Risks Associated with Solid Waste Management in the Informal Sector of Gweru, Zimbabwe

PubMed Central

Jerie, Steven

2016-01-01

This study identifies and analyses the occupational risks associated with solid waste management practices in the informal enterprises of Gweru. Many concerns have been raised about the potential harm from waste to the environment and the general public, but the risks and consequent costs of occupational hazards in waste management have received little attention in the rush to adopt or adapt technologies such as composting. A multimethods research design that triangulates qualitative and quantitative research paradigms is employed in this study. The quantitative design involves physical characterisation of solid waste through material component separation and measurements as well as a questionnaire survey that investigates the risks associated with waste management. The qualitative component includes interviews, open-ended questionnaires, and field observations. Occupational risks occur at every stage in the waste management process, from the point where workers handle waste in the enterprises for collection or recycling to the point of ultimate disposal. Key findings from the study revealed that solid waste management practices are dominated by manual handling tasks hence the higher incidents of muscular-skeletal disorders. Other safety and health hazards associated with waste management in the informal enterprises of Gweru include incidents of diarrhoea, viral hepatitis, and higher incidents of obstructive and restrictive disorders. PMID:27418935

Risk assessment for arsenic-contaminated groundwater along River Indus in Pakistan.

PubMed

Rabbani, Unaib; Mahar, Gohar; Siddique, Azhar; Fatmi, Zafar

2017-02-01

The study determined the risk zone and estimated the population at risk of adverse health effects for arsenic exposure along the bank of River Indus in Pakistan. A cross-sectional survey was conducted in 216 randomly selected villages of one of the districts along River Indus. Wells of ten households from each village were selected to measure arsenic levels. The location of wells was identified using global positioning system device, and spatial variations of the groundwater contamination were assessed using geographical information system tools. Using layers of contaminated drinking water wells according to arsenic levels and population with major landmarks, a risk zone and estimated population at risk were determined, which were exposed to arsenic level ≥10 µg/L. Drinking wells with arsenic levels of ≥10 µg/L were concentrated within 18 km near the river bank. Based on these estimates, a total of 13 million people were exposed to ≥10 µg/L arsenic concentration along the course of River Indus traversing through 27 districts in Pakistan. This information would help the researchers in designing health effect studies on arsenic and policy makers in allocating resources for designing focused interventions for arsenic mitigation in Pakistan. The study methods have implication on similar populations which are affected along rivers due to arsenic contamination.

Occupational Risks Associated with Solid Waste Management in the Informal Sector of Gweru, Zimbabwe.

PubMed

Jerie, Steven

2016-01-01

This study identifies and analyses the occupational risks associated with solid waste management practices in the informal enterprises of Gweru. Many concerns have been raised about the potential harm from waste to the environment and the general public, but the risks and consequent costs of occupational hazards in waste management have received little attention in the rush to adopt or adapt technologies such as composting. A multimethods research design that triangulates qualitative and quantitative research paradigms is employed in this study. The quantitative design involves physical characterisation of solid waste through material component separation and measurements as well as a questionnaire survey that investigates the risks associated with waste management. The qualitative component includes interviews, open-ended questionnaires, and field observations. Occupational risks occur at every stage in the waste management process, from the point where workers handle waste in the enterprises for collection or recycling to the point of ultimate disposal. Key findings from the study revealed that solid waste management practices are dominated by manual handling tasks hence the higher incidents of muscular-skeletal disorders. Other safety and health hazards associated with waste management in the informal enterprises of Gweru include incidents of diarrhoea, viral hepatitis, and higher incidents of obstructive and restrictive disorders.

Derailment-based Fault Tree Analysis on Risk Management of Railway Turnout Systems

NASA Astrophysics Data System (ADS)

Dindar, Serdar; Kaewunruen, Sakdirat; An, Min; Gigante-Barrera, Ángel

2017-10-01

Railway turnouts are fundamental mechanical infrastructures, which allow a rolling stock to divert one direction to another. As those are of a large number of engineering subsystems, e.g. track, signalling, earthworks, these particular sub-systems are expected to induce high potential through various kind of failure mechanisms. This could be a cause of any catastrophic event. A derailment, one of undesirable events in railway operation, often results, albeit rare occurs, in damaging to rolling stock, railway infrastructure and disrupt service, and has the potential to cause casualties and even loss of lives. As a result, it is quite significant that a well-designed risk analysis is performed to create awareness of hazards and to identify what parts of the systems may be at risk. This study will focus on all types of environment based failures as a result of numerous contributing factors noted officially as accident reports. This risk analysis is designed to help industry to minimise the occurrence of accidents at railway turnouts. The methodology of the study relies on accurate assessment of derailment likelihood, and is based on statistical multiple factors-integrated accident rate analysis. The study is prepared in the way of establishing product risks and faults, and showing the impact of potential process by Boolean algebra.

Addressing risk factors for child abuse among high risk pregnant women: design of a randomised controlled trial of the nurse family partnership in Dutch preventive health care.

PubMed

Mejdoubi, Jamila; van den Heijkant, Silvia; Struijf, Elle; van Leerdam, Frank; HiraSing, Remy; Crijnen, Alfons

2011-10-21

Low socio-economic status combined with other risk factors affects a person's physical and psychosocial health from childhood to adulthood. The societal impact of these problems is huge, and the consequences carry on into the next generation(s). Although several studies show these consequences, only a few actually intervene on these issues. In the United States, the Nurse Family Partnership focuses on high risk pregnant women and their children. The main goal of this program is primary prevention of child abuse. The Netherlands is the first country outside the United States allowed to translate and culturally adapt the Nurse Family Partnership into VoorZorg. The aim of the present study is to assess whether VoorZorg is as effective in the Netherland as in the United States. The study consists of three partly overlapping phases. Phase 1 was the translation and cultural adaptation of Nurse Family Partnership and the design of a two-stage selection procedure. Phase 2 was a pilot study to examine the conditions for implementation. Phase 3 is the randomized controlled trial of VoorZorg compared to the care as usual. Primary outcome measures were smoking cessation during pregnancy and after birth, birth outcomes, child development, child abuse and domestic violence. The secondary outcome measure was the number of risk factors present. This study shows that the Nurse Family Partnership was successfully translated and culturally adapted into the Dutch health care system and that this program fulfills the needs of high-risk pregnant women. We hypothesize that this program will be effective in addressing risk factors that operate during pregnancy and childhood and compromise fetal and child development. Current Controlled Trials ISRCTN16131117.

The Emergency Department Safety Assessment and Follow-up Evaluation (ED-SAFE): method and design considerations.

PubMed

Boudreaux, Edwin D; Miller, Ivan; Goldstein, Amy B; Sullivan, Ashley F; Allen, Michael H; Manton, Anne P; Arias, Sarah A; Camargo, Carlos A

2013-09-01

Due to the concentration of individuals at-risk for suicide, an emergency department visit represents an opportune time for suicide risk screening and intervention. The Emergency Department Safety Assessment and Follow-up Evaluation (ED-SAFE) uses a quasi-experimental, interrupted time series design to evaluate whether (1) a practical approach to universally screening ED patients for suicide risk leads to improved detection of suicide risk and (2) a multi-component intervention delivered during and after the ED visit improves suicide-related outcomes. This paper summarizes the ED-SAFE's study design and methods within the context of considerations relevant to effectiveness research in suicide prevention and pertinent human participants concerns. 1440 suicidal individuals, from 8 general ED's nationally will be enrolled during three sequential phases of data collection (480 individuals/phase): (1) Treatment as Usual; (2) Universal Screening; and (3) Intervention. Data from the three phases will inform two separate evaluations: Screening Outcome (Phases 1 and 2) and Intervention (Phases 2 and 3). Individuals will be followed for 12 months. The primary study outcome is a composite reflecting completed suicide, attempted suicide, aborted or interrupted attempts, and implementation of rescue procedures during an outcome assessment. While 'classic' randomized control trials (RCT) are typically selected over quasi-experimental designs, ethical and methodological issues may make an RCT a poor fit for complex interventions in an applied setting, such as the ED. ED-SAFE represents an innovative approach to examining the complex public health issue of suicide prevention through a multi-phase, quasi-experimental design embedded in 'real world' clinical settings. Copyright © 2013 Elsevier Inc. All rights reserved.

Indiana's Twenty-First Century Scholars Program

ERIC Educational Resources Information Center

Wandel, Tamara L.

2004-01-01

This case study analyzes the impact of Indiana's Twenty-First Century Scholars college tuition discount program on the academic self-efficacy of high-risk, low-income students. The program is designed to increase the number of high-risk individuals attending college. The self-efficacy "training" of the program helps instill and reinforce the…

Iron metabolism in African American women in the second and third trimesters of high-risk pregnancies

USDA-ARS?s Scientific Manuscript database

Objective: To examine iron metabolism during the second and third trimesters in African American women with high-risk pregnancies. Design: Longitudinal pilot study. Setting: Large, university-based, urban Midwestern U.S. medical center. Participants: Convenience sample of 32 African American wome...

First Year Experience for At-Risk College Students

ERIC Educational Resources Information Center

Connolly, Sara; Flynn, Ellen E.; Jemmott, Jill; Oestreicher, Edina

2017-01-01

In this study, we explored whether a uniquely designed First Year Experience (FYE) class for newly admitted at-risk college students would increase academic success; help students avoid academic probation; and increase retention for the following semester. Participants included 40 students (75% African Americans, 20% Hispanic Americans, and 5%…

Predicting Reading Ability for Bilingual Latino Children Using Dynamic Assessment

ERIC Educational Resources Information Center

Petersen, Douglas B.; Gillam, Ronald B.

2015-01-01

This study investigated the predictive validity of a dynamic assessment designed to evaluate later risk for reading difficulty in bilingual Latino children at risk for language impairment. During kindergarten, 63 bilingual Latino children completed a dynamic assessment nonsense-word recoding task that yielded pretest to posttest gain scores,…

High Risk Drinking among Non-Affiliated College Students

ERIC Educational Resources Information Center

Smith, Margaret; Finneran, John; Droppa, Marj

2014-01-01

This study investigated the high risk drinking practices of unaffiliated college students who are not involved in formal athletics, fraternities, or sororities. Using a qualitative research design, the investigators interviewed students at a northeast public college in fall 2010 to learn about unaffiliated students' drinking experiences and their…

The ethics of HIV "cure" research: what can we learn from consent forms?

PubMed

Henderson, Gail E

2015-01-01

The advent of HIV "cure" research has generated enormous attention, but also concern about its potential to engender false hope, leading to overestimation of benefits and underestimation of risks, and about recruiting relatively healthy participants to studies with uncertain or serious risks. Currently, little is known about potential ethical problems in the ways that informed consent for HIV cure research is described to potential participants. As a first step to address this question, early phase, HIV "cure" research consent forms were analyzed to assess how study aims and potential risks and benefits are presented. Thirteen consent forms from a diverse group of clinical studies were selected to represent the major categories of cure research, including 11 interventional (gene transfer, vaccine intensification, treatment interruption, and latency reversing) and two observational. Consent forms were coded using seven categories, abstracting data on study purpose and design, participant selection criteria, presentation of risks and benefits of participation, and potential return of research results. Findings demonstrate variation and deficiencies that merit attention, but that can largely be addressed by turning to existing guidance about early phase research and specific study designs from other research contexts. The most challenging of these is ensuring that clear, specific, and consistent language is used to describe study aims, risks, benefits, and possible return of results. Informed consent for HIV "cure" research represents an opportunity to apply relevant existing guidance, measure the effectiveness of its application, and develop standardized best-practice policies for consent forms and processes.

Strategic Risk Assessment: Where We Are and How We Got There

DTIC Science & Technology

1990-04-06

understanding an ill-de ined problem.ŗ The challenge for the designers of a risk assessment methodology was that the process selected must consider the objective...STRATEGIC RISK ASSESSMENT: WHERE WE ARE AND HOW WE GOT THERE BY LIEUTENANT COLONEL JOHN B. McDOUGLE, SC DlSTRIBUTION STATEMENT A: Approved for publiC...ACCESSION NO.! 1 RECIPIENT’S CATALOG NUMBER 4. TITLE (and Subtitle) -. TYPE OF REPORT 6 PERIOD COVERED Strategic Risk Assessment: Where We Are Study Project

Design of a RCT evaluating the (cost-) effectiveness of a lifestyle intervention for male construction workers at risk for cardiovascular disease: The Health under Construction study

PubMed Central

Groeneveld, Iris F; Proper, Karin I; van der Beek, Allard J; van Duivenbooden, Cor; van Mechelen, Willem

2008-01-01

Background Of all workers in Dutch construction industry, 20% has an elevated risk of cardiovascular disease (CVD). A major risk factor for CVD risk is an unhealthy lifestyle. The aim of our study is to design a lifestyle intervention for construction workers with an elevated CVD risk, and to evaluate its (cost-) effectiveness. Methods/Design In a RCT, 692 participants will be randomised to either the control or the intervention group. The control group will receive usual care. For the intervention group, a lifestyle intervention has been designed based on interviews and current literature. The intervention will last 6 months and will comprise 3 face-to-face and 4 telephone contacts, consisting of individual counselling aimed at increasing daily physical activity (PA) and improving dietary behaviour, and/or smoking cessation. Counselling will take place at the Occupational Health Service (OHS), and will be done according to motivational interviewing (MI). Additional written information about healthy lifestyle will also be provided to those in the intervention group. At baseline, after 6 and after 12 months, measurements will take place. Primary outcome variables will be the lifestyle behaviours of concern, i.e. daily PA, dietary intake, and smoking status. Secondary outcome variables will be body mass index (BMI), systolic and diastolic blood pressure, total and HDL blood cholesterol, Hba1c and cardio-respiratory fitness (CRF). Sickness absenteeism and cost-effectiveness will be assessed as well. Multilevel analysis will be performed to compare all outcome measures between the intervention group and the control group. Discussion By improving lifestyle, CVD risk may be lowered, yielding benefits for both employee and employer. If proven effective, this lifestyle intervention will be implemented on a larger scale within the Occupational Health Services in construction industry. Trial registration Current Controlled Trials ISRCTN60545588 PMID:18173844

Web-Based Study of Risk Factors for Pain Exacerbation in Osteoarthritis of the Knee (SPARK-Web): Design and Rationale

PubMed Central

Metcalf, Ben; Zhang, Yuqing; Bennell, Kim; March, Lyn; Hunter, David J

2015-01-01

Background Knee osteoarthritis (OA) is the most frequent cause of limited mobility and diminished quality of life. Pain is the main symptom that drives individuals with knee OA to seek medical care and a recognized antecedent to disability and eventually joint replacement. Many persons with symptomatic knee OA experience recurrent pain exacerbations. Knowledge and clarification of risk factors for pain exacerbation may allow those affected to minimize reoccurrence of these episodes. Objective The aim of this study is to use a Web-based case-crossover design to identify risk factors for knee pain exacerbations in persons with symptomatic knee OA. Methods Web-based case-crossover design is used to study persons with symptomatic knee OA. Participants with knee pain and radiographic knee OA will be recruited and followed for 90 days. Participants will complete an online questionnaire at the baseline and every 10 days thereafter (totaling up to 10 control-period questionnaires); participants will also be asked to report online when they experience an episode of increased knee pain. Pain exacerbation will be defined as an increase in knee pain severity of two points from baseline on a numeric rating scale (NRS 0-10). Physical activity, footwear, knee injury, medication use, climate, psychological factors, and their possible interactions will be assessed as potential triggers for pain exacerbation using conditional logistic regression models. Results This project has been funded by the National Health and Medical Research Council (NHMRC). The enrollment for the study has started. So far, 343 participants have been enrolled. The study is expected to be finished in October 2015. Conclusions This study will identify risk factors for pain exacerbations in knee OA. The identification and possible modification/elimination of such risk factors will help to prevent the reoccurrence of pain exacerbation episodes and therefore improve knee OA management. PMID:26156210

Childhood obesity prevention in rural settings: background, rationale, and study design of ‘4-Health,’ a parent-only intervention

PubMed Central

2012-01-01

Background Childhood obesity in rural communities is a serious but understudied problem. The current experiment aims to assess a wide range of obesity risk factors among rural youth and to offer an 8-month intervention program for parents to reduce obesity risk in their preteen child. Methods/Design A two-group, repeated measures design is used to assess the effectiveness of the 4-Health intervention program. Assessments include anthropometric measures, child self-evaluations, parent self-evaluations, and parent evaluations of child. County Extension agents from 21 rural Montana counties recruit approximately 150 parent–child dyads and counties are semi-randomly assigned to the active intervention group (4-Health Educational Program) or a “best-practices” (Healthy Living Information) control group. Discussion This study will shed light on the effectiveness of this parent-only intervention strategy in reducing obesity risk factors among rural preteens. The 4-Health program is designed to provide information and skills development for busy rural parents that will increase healthy lifestyles of their preteen children and improve the parents’ ability to intervene effectively in the lives of their families during this critical developmental period. Trial registration ClinicalTrials.gov ID: NCT01510587 PMID:22471650

Subgroup identification of early preterm birth (ePTB): informing a future prospective enrichment clinical trial design.

PubMed

Zhang, Chuanwu; Garrard, Lili; Keighley, John; Carlson, Susan; Gajewski, Byron

2017-01-10

Despite the widely recognized association between the severity of early preterm birth (ePTB) and its related severe diseases, little is known about the potential risk factors of ePTB and the sub-population with high risk of ePTB. Moreover, motivated by a future confirmatory clinical trial to identify whether supplementing pregnant women with docosahexaenoic acid (DHA) has a different effect on the risk subgroup population or not in terms of ePTB prevalence, this study aims to identify potential risk subgroups and risk factors for ePTB, defined as babies born less than 34 weeks of gestation. The analysis data (N = 3,994,872) were obtained from CDC and NCHS' 2014 Natality public data file. The sample was split into independent training and validation cohorts for model generation and model assessment, respectively. Logistic regression and CART models were used to examine potential ePTB risk predictors and their interactions, including mothers' age, nativity, race, Hispanic origin, marital status, education, pre-pregnancy smoking status, pre-pregnancy BMI, pre-pregnancy diabetes status, pre-pregnancy hypertension status, previous preterm birth status, infertility treatment usage status, fertility enhancing drug usage status, and delivery payment source. Both logistic regression models with either 14 or 10 ePTB risk factors produced the same C-index (0.646) based on the training cohort. The C-index of the logistic regression model based on 10 predictors was 0.645 for the validation cohort. Both C-indexes indicated a good discrimination and acceptable model fit. The CART model identified preterm birth history and race as the most important risk factors, and revealed that the subgroup with a preterm birth history and a race designation as Black had the highest risk for ePTB. The c-index and misclassification rate were 0.579 and 0.034 for the training cohort, and 0.578 and 0.034 for the validation cohort, respectively. This study revealed 14 maternal characteristic variables that reliably identified risk for ePTB through either logistic regression model and/or a CART model. Moreover, both models efficiently identify risk subgroups for further enrichment clinical trial design.

Use of case-time-control design in pharmacovigilance applications: exploration with high-risk medications and unplanned hospital admissions in the Western Australian elderly.

PubMed

Price, Sylvie D; Holman, C D'Arcy J; Sanfilippo, Frank M; Emery, Jon D

2013-11-01

To use a case-time-control design to derive preliminary estimates of unplanned hospitalisations attributable to suspected high-risk medications in elderly Western Australians. Using pharmaceutical claims linked to inpatient and other health records, the study applied a case-time-control design and conditional logistic regression to estimate odds ratios (ORs) for unplanned hospital admissions associated with anticoagulants, antirheumatics, opioids, corticosteroids and four major groups of cardiovascular drugs. Attributable fractions (AFs) were derived from the ORs to estimate the number and proportion of admissions associated with drug exposure. Results were compared with those obtained from a more conventional method using International Classification of Diseases (ICD) external cause codes to identify admissions related to adverse drug events. The study involved 1 899 699 index hospital admissions. Six of the eight drug groups were associated with an increased risk of unplanned hospitalisation, opioids (adjusted OR = 1.81, 95%CI 1.75-1.88; AF = 44.9%) and corticosteroids (1.48, 1.42-1.54; 32.2%) linked with the highest risks. For all six, the estimated number of hospitalisations attributed to the medication in the exposed was higher (two to 31-fold) when derived from the case-time-control design compared with identification from ICD codes. This study provides an alternative approach for identifying potentially harmful medications and suggests that the use of ICD external causes may underestimate adverse drug events. It takes drug exposure into account, can be applied to individual medications and may overcome under-reporting issues associated with conventional methods. The approach shows great potential as part of a post-marketing pharmacovigilance monitoring system in Australia and elsewhere. Copyright © 2013 John Wiley & Sons, Ltd.

Work design and management in the manufacturing sector: development and validation of the Work Organisation Assessment Questionnaire.

PubMed

Griffiths, A; Cox, T; Karanika, M; Khan, S; Tomás, J M

2006-10-01

To examine the factor structure, reliability, and validity of a new context-specific questionnaire for the assessment of work and organisational factors. The Work Organisation Assessment Questionnaire (WOAQ) was developed as part of a risk assessment and risk reduction methodology for hazards inherent in the design and management of work in the manufacturing sector. Two studies were conducted. Data were collected from 524 white- and blue-collar employees from a range of manufacturing companies. Exploratory factor analysis was carried out on 28 items that described the most commonly reported failures of work design and management in companies in the manufacturing sector. Concurrent validity data were also collected. A reliability study was conducted with a further 156 employees. Principal component analysis, with varimax rotation, revealed a strong 28-item, five factor structure. The factors were named: quality of relationships with management, reward and recognition, workload, quality of relationships with colleagues, and quality of physical environment. Analyses also revealed a more general summative factor. Results indicated that the questionnaire has good internal consistency and test-retest reliability and validity. Being associated with poor employee health and changes in health related behaviour, the WOAQ factors are possible hazards. It is argued that the strength of those associations offers some estimation of risk. Feedback from the organisations involved indicated that the WOAQ was easy to use and meaningful for them as part of their risk assessment procedures. The studies reported here describe a model of the hazards to employee health and health related behaviour inherent in the design and management of work in the manufacturing sector. It offers an instrument for their assessment. The scales derived which form the WOAQ were shown to be reliable, valid, and meaningful to the user population.

Adaptive sampling in research on risk-related behaviors.

PubMed

Thompson, Steven K; Collins, Linda M

2002-11-01

This article introduces adaptive sampling designs to substance use researchers. Adaptive sampling is particularly useful when the population of interest is rare, unevenly distributed, hidden, or hard to reach. Examples of such populations are injection drug users, individuals at high risk for HIV/AIDS, and young adolescents who are nicotine dependent. In conventional sampling, the sampling design is based entirely on a priori information, and is fixed before the study begins. By contrast, in adaptive sampling, the sampling design adapts based on observations made during the survey; for example, drug users may be asked to refer other drug users to the researcher. In the present article several adaptive sampling designs are discussed. Link-tracing designs such as snowball sampling, random walk methods, and network sampling are described, along with adaptive allocation and adaptive cluster sampling. It is stressed that special estimation procedures taking the sampling design into account are needed when adaptive sampling has been used. These procedures yield estimates that are considerably better than conventional estimates. For rare and clustered populations adaptive designs can give substantial gains in efficiency over conventional designs, and for hidden populations link-tracing and other adaptive procedures may provide the only practical way to obtain a sample large enough for the study objectives.

Study design for a hepatitis B vaccine trial.

PubMed Central

Lustbader, E D; London, W T; Blumberg, B S

1976-01-01

A short-time trial of small sample size for an evaluation of the hepatitis B vaccine is proposed and designed. The vaccine is based on the premise that antibody to the surface antigen of the hepatitis B virus is protective against viral infection. This premise is verified by using the presence of the surface antigen as the marker of infection and comparing infection rates in renal dialysis patients who had naturally acquired antibody to patients without antibody. Patients with antibody have an extremely low risk of infection. The probability of remaining uninfected decreases at an exponential rate for patients without antibody, implying a constant risk of infection at any point in time. The study design described makes use of this time independence and the observed infection rates to formulate a clinical trial which can be accomplished with a relatively small number of patients. This design might be useful if, in preliminary studies, it is shown that the vaccine produces antibody in the patients and that protection against hepatitis B virus would be beneficial to the patients. PMID:1062809

Prenatal Risk Factors and the Etiology of ADHD-Review of Existing Evidence.

PubMed

Sciberras, Emma; Mulraney, Melissa; Silva, Desiree; Coghill, David

2017-01-01

While it is well accepted that attention-deficit/hyperactivity disorder (ADHD) is a highly heritable disorder, not all of the risk is genetic. It is estimated that between 10 and 40% of the variance associated with ADHD is likely to be accounted for by environmental factors. There is considerable interest in the role that the prenatal environment might play in the development of ADHD with previous reviews concluding that despite demonstration of associations between prenatal risk factors (e.g. prematurity, maternal smoking during pregnancy) and ADHD, there remains insufficient evidence to support a definite causal relationship. This article provides an update of research investigating the relationship between prenatal risk factors and ADHD published over the past 3 years. Recently, several epidemiological and data linkage studies have made substantial contributions to our understanding of this relationship. In particular, these studies have started to account for some of the genetic and familial confounds that, when taken into account, throw several established findings into doubt. None of the proposed prenatal risk factors can be confirmed as causal for ADHD, and the stronger the study design, the less likely it is to support an association. We need a new benchmark for studies investigating the etiology of ADHD whereby there is an expectation not only that data will be collected prospectively but also that the design allows the broad range of genetic and familial factors to be accounted for.

Risk factors for asthma and allergy associated with urban migration: background and methodology of a cross-sectional study in Afro-Ecuadorian school children in Northeastern Ecuador (Esmeraldas-SCAALA Study)

PubMed Central

Cooper, Philip J; Chico, Martha E; Vaca, Maritza G; Rodriguez, Alejandro; Alcântara-Neves, Neuza M; Genser, Bernd; de Carvalho, Lain Pontes; Stein, Renato T; Cruz, Alvaro A; Rodrigues, Laura C; Barreto, Mauricio L

2006-01-01

Background Asthma and allergic diseases are becoming increasingly frequent in children in urban centres of Latin America although the prevalence of allergic disease is still low in rural areas. Understanding better why the prevalence of asthma is greater in urban migrant populations and the role of risk factors such as life style and environmental exposures, may be key to understand what is behind this trend. Methods/design The Esmeraldas-SCAALA (Social Changes, Asthma and Allergy in Latin America) study consists of cross-sectional and nested case-control studies of school children in rural and urban areas of Esmeraldas Province in Ecuador. The cross-sectional study will investigate risk factors for atopy and allergic disease in rural and migrant urban Afro-Ecuadorian school children and the nested case-control study will examine environmental, biologic and social risk factors for asthma among asthma cases and non-asthmatic controls from the cross-sectional study. Data will be collected through standardised questionnaires, skin prick testing to relevant aeroallergen extracts, stool examinations for parasites, blood sampling (for measurement of IgE, interleukins and other immunological parameters), anthropometric measurements for assessment of nutritional status, exercise testing for assessment of exercise-induced bronchospasm and dust sampling for measurement of household endotoxin and allergen levels. Discussion The information will be used to identify the factors associated with an increased risk of asthma and allergies in migrant and urbanizing populations, to improve the understanding of the causes of the increase in asthma prevalence and to identify potentially modifiable factors to inform the design of prevention programmes to reduce the risk of allergy in urban populations in Latin America. PMID:16970809

Vibration Analysis of a Split Path Gearbox

NASA Technical Reports Server (NTRS)

Krantz, Timothy L.; Rashidi, Majid

1995-01-01

Split path gearboxes can be attractive alternatives to the common planetary designs for rotorcraft, but because they have seen little use, they are relatively high risk designs. To help reduce the risk of fielding a rotorcraft with a split path gearbox, the vibration and dynamic characteristics of such a gearbox were studied. A mathematical model was developed by using the Lagrangian method, and it was applied to study the effect of three design variables on the natural frequencies and vibration energy of the gearbox. The first design variable, shaft angle, had little influence on the natural frequencies. The second variable, mesh phasing, had a strong effect on the levels of vibration energy, with phase angles of 0 deg and 180 deg producing low vibration levels. The third design variable, the stiffness of the shafts connecting the spur gears to the helical pinions, strongly influenced the natural frequencies of some of the vibration modes, including two of the dominant modes. We found that, to achieve the lowest level of vibration energy, the natural frequencies of these two dominant modes should be less than those of the main excitation sources.

The Stamp-in-Safety programme, an intervention to promote better supervision of children on childcare centre playgrounds: an evaluation in an urban setting.

PubMed

Chelvakumar, Gayathri; Sheehan, Karen; Hill, Amy L; Lowe, Danita; Mandich, Nicole; Schwebel, David C

2010-10-01

Using a non-equivalent control group design, this report evaluated a previously studied behavioural intervention, the Stamp-in-Safety programme, which is designed to reduce the injury risk for young children on playgrounds at childcare centres by increasing the quality of adult supervision and rewarding children for safe play. In an urban, commercial childcare centre, 71 children aged 3-5 years and 15 teachers participated. Primary outcome measures were teacher verbalisations (warnings, explanations, redirects), teacher location (core, outskirt, or fringe of playground), child risk-taking behaviours (using equipment appropriately) and the number of injuries on the playground. Analyses revealed that the intervention had a modest positive effect in promoting safer teacher and child playground behaviours. This study reaffirms previous results that the Stamp-in-Safety programme is an effective method to decrease the risk of playground injuries at childcare centres.

Relating design and environmental variables to reliability

NASA Astrophysics Data System (ADS)

Kolarik, William J.; Landers, Thomas L.

The combination of space application and nuclear power source demands high reliability hardware. The possibilities of failure, either an inability to provide power or a catastrophic accident, must be minimized. Nuclear power experiences on the ground have led to highly sophisticated probabilistic risk assessment procedures, most of which require quantitative information to adequately assess such risks. In the area of hardware risk analysis, reliability information plays a key role. One of the lessons learned from the Three Mile Island experience is that thorough analyses of critical components are essential. Nuclear grade equipment shows some reliability advantages over commercial. However, no statistically significant difference has been found. A recent study pertaining to spacecraft electronics reliability, examined some 2500 malfunctions on more than 300 aircraft. The study classified the equipment failures into seven general categories. Design deficiencies and lack of environmental protection accounted for about half of all failures. Within each class, limited reliability modeling was performed using a Weibull failure model.

Risk Factors for Nursing Home Placement in Alzheimer's Disease: A Longitudinal Study of Cognition, ADL, Service Utilization, and Cholinesterase Inhibitor Treatment

ERIC Educational Resources Information Center

Wattmo, Carina; Wallin, Asa K.; Londos, Elisabet; Minthon, Lennart

2011-01-01

Purpose of the Study: To identify risk factors for early nursing home placement (NHP) in Alzheimer's disease (AD), focusing on the impact of longitudinal change in cognition, activities of daily living (ADL), service utilization, and cholinesterase inhibitor treatment (ChEI). Design and Methods: In an open, 3-year, prospective, multicenter study…

Prevalence Study of the Risk of Burns in the Public Schools Population in Charleston, South Carolina (Under the Direction of Stanley Schuman).

ERIC Educational Resources Information Center

Littlefield, Charlyne Butler

This Charleston Burn Study was designed to determine the prevalence of the burn risks in the public school population in Charleston, South Carolina. Twelve schools representing a cross section of urban, suburban, rural and military populations participated in the project. Students completed forms that revealed their experience with burns and…

Can Roadway Design be used to Mitigate Air Quality Impacts from Traffic?

EPA Science Inventory

Recent studies have confirmed the increased risks to human health for populations near roadways with large traffic volumes. This paper summarizes methods in which these impacts may be mitigated by infrastructure design options such as roadway configuration and roadside structures...

Does Growth in the Executive System of Working Memory Underlie Growth in Literacy for Bilingual Children with and without Reading Disabilities?

ERIC Educational Resources Information Center

Swanson, H. Lee; Orosco, Michael J.; Kudo, Milagros

2017-01-01

This cohort-sequential study explored the components of working memory (WM) that underlie second language (L2) reading growth in 450 children at risk and not at risk for reading disabilities (RD) whose first language is Spanish. English language learners designated as balanced and nonbalanced bilinguals with and without risk for RD in Grades 1, 2,…

The role of personality traits and driving experience in self-reported risky driving behaviors and accident risk among Chinese drivers.

PubMed

Tao, Da; Zhang, Rui; Qu, Xingda

2017-02-01

The purpose of this study was to explore the role of personality traits and driving experience in the prediction of risky driving behaviors and accident risk among Chinese population. A convenience sample of drivers (n=511; mean (SD) age=34.2 (8.8) years) completed a self-report questionnaire that was designed based on validated scales for measuring personality traits, risky driving behaviors and self-reported accident risk. Results from structural equation modeling analysis demonstrated that the data fit well with our theoretical model. While showing no direct effects on accident risk, personality traits had direct effects on risky driving behaviors, and yielded indirect effects on accident risk mediated by risky driving behaviors. Both driving experience and risky driving behaviors directly predicted accident risk and accounted for 15% of its variance. There was little gender difference in personality traits, risky driving behaviors and accident risk. The findings emphasized the importance of personality traits and driving experience in the understanding of risky driving behaviors and accident risk among Chinese drivers and provided new insight into the design of evidence-based driving education and accident prevention interventions. Copyright © 2016 Elsevier Ltd. All rights reserved.

Citrus fruit intake and bladder cancer risk: a meta-analysis of observational studies.

PubMed

Liang, Sudong; Lv, Gaofei; Chen, Weikai; Jiang, Jianxin; Wang, Jingqun

2014-11-01

Epidemiological studies have investigated the association between citrus fruit and bladder cancer risk; however, the results are inconsistent. To assess these issues, we conducted a meta-analysis of currently available studies. We identified relevant articles by searching the MEDLINE and EMBASE databases. We calculated the summary relative risk (RR) with 95% confidence interval (95% CI) using a random effect model. We included eight case-control studies and six cohort studies in the meta-analysis. There was a significant inverse association between citrus fruit intake and bladder cancer risk in all pooled studies (RR: 0.85; 95% CI, 0.76-0.94) and case-control studies (RR: 0.77; 95% CI, 0.64-0.92), but not in the cohort studies (RR: 0.96; 95% CI, 0.87-1.07). Our results suggest that citrus fruit intake is related to decreased bladder cancer risk. Subsequent well-designed, large prospective studies are needed to obtain better understanding of this relationship.

Multi crop model climate risk country-level management design: case study on the Tanzanian maize production system

NASA Astrophysics Data System (ADS)

Chavez, E.

2015-12-01

Future climate projections indicate that a very serious consequence of post-industrial anthropogenic global warming is the likelihood of the greater frequency and intensity of extreme hydrometeorological events such as heat waves, droughts, storms, and floods. The design of national and international policies targeted at building more resilient and environmentally sustainable food systems needs to rely on access to robust and reliable data which is largely absent. In this context, the improvement of the modelling of current and future agricultural production losses using the unifying language of risk is paramount. In this study, we use a methodology that allows the integration of the current understanding of the various interacting systems of climate, agro-environment, crops, and the economy to determine short to long-term risk estimates of crop production loss, in different environmental, climate, and adaptation scenarios. This methodology is applied to Tanzania to assess optimum risk reduction and maize production increase paths in different climate scenarios. The simulations carried out use inputs from three different crop models (DSSAT, APSIM, WRSI) run in different technological scenarios and thus allowing to estimate crop model-driven risk exposure estimation bias. The results obtained also allow distinguishing different region-specific optimum climate risk reduction policies subject to historical as well as RCP2.5 and RCP8.5 climate scenarios. The region-specific risk profiles obtained provide a simple framework to determine cost-effective risk management policies for Tanzania and allow to optimally combine investments in risk reduction and risk transfer.

Optimizing spacecraft design - optimization engine development : progress and plans

NASA Technical Reports Server (NTRS)

Cornford, Steven L.; Feather, Martin S.; Dunphy, Julia R; Salcedo, Jose; Menzies, Tim

2003-01-01

At JPL and NASA, a process has been developed to perform life cycle risk management. This process requires users to identify: goals and objectives to be achieved (and their relative priorities), the various risks to achieving those goals and objectives, and options for risk mitigation (prevention, detection ahead of time, and alleviation). Risks are broadly defined to include the risk of failing to design a system with adequate performance, compatibility and robustness in addition to more traditional implementation and operational risks. The options for mitigating these different kinds of risks can include architectural and design choices, technology plans and technology back-up options, test-bed and simulation options, engineering models and hardware/software development techniques and other more traditional risk reduction techniques.

Information and Risk Modification Trial (INFORM): design of a randomised controlled trial of communicating different types of information about coronary heart disease risk, alongside lifestyle advice, to achieve change in health-related behaviour.

PubMed

Silarova, Barbora; Lucas, Joanne; Butterworth, Adam S; Di Angelantonio, Emanuele; Girling, Christine; Lawrence, Kathryn; Mackintosh, Stuart; Moore, Carmel; Payne, Rupert A; Sharp, Stephen J; Shefer, Guy; Tolkien, Zoe; Usher-Smith, Juliet; Walker, Matthew; Danesh, John; Griffin, Simon

2015-09-07

Cardiovascular disease (CVD) remains the leading cause of death globally. Primary prevention of CVD requires cost-effective strategies to identify individuals at high risk in order to help target preventive interventions. An integral part of this approach is the use of CVD risk scores. Limitations in previous studies have prevented reliable inference about the potential advantages and the potential harms of using CVD risk scores as part of preventive strategies. We aim to evaluate short-term effects of providing different types of information about coronary heart disease (CHD) risk, alongside lifestyle advice, on health-related behaviours. In a parallel-group, open randomised trial, we are allocating 932 male and female blood donors with no previous history of CVD aged 40-84 years in England to either no intervention (control group) or to one of three active intervention groups: i) lifestyle advice only; ii) lifestyle advice plus information on estimated 10-year CHD risk based on phenotypic characteristics; and iii) lifestyle advice plus information on estimated 10-year CHD risk based on phenotypic and genetic characteristics. The primary outcome is change in objectively measured physical activity. Secondary outcomes include: objectively measured dietary behaviours; cardiovascular risk factors; current medication and healthcare usage; perceived risk; cognitive evaluation of provision of CHD risk scores; and psychological outcomes. The follow-up assessment takes place 12 weeks after randomisation. The experiences, attitudes and concerns of a subset of participants will be also studied using individual interviews and focus groups. The INFORM study has been designed to provide robust findings about the short-term effects of providing different types of information on estimated 10-year CHD risk and lifestyle advice on health-related behaviours. Current Controlled Trials ISRCTN17721237 . Registered 12 January 2015.

Use of Physiologically Based Pharmacokinetic (PBPK) Models ...

EPA Pesticide Factsheets

EPA announced the availability of the final report, Use of Physiologically Based Pharmacokinetic (PBPK) Models to Quantify the Impact of Human Age and Interindividual Differences in Physiology and Biochemistry Pertinent to Risk Final Report for Cooperative Agreement. This report describes and demonstrates techniques necessary to extrapolate and incorporate in vitro derived metabolic rate constants in PBPK models. It also includes two case study examples designed to demonstrate the applicability of such data for health risk assessment and addresses the quantification, extrapolation and interpretation of advanced biochemical information on human interindividual variability of chemical metabolism for risk assessment application. It comprises five chapters; topics and results covered in the first four chapters have been published in the peer reviewed scientific literature. Topics covered include: Data Quality ObjectivesExperimental FrameworkRequired DataTwo example case studies that develop and incorporate in vitro metabolic rate constants in PBPK models designed to quantify human interindividual variability to better direct the choice of uncertainty factors for health risk assessment. This report is intended to serve as a reference document for risk assors to use when quantifying, extrapolating, and interpretating advanced biochemical information about human interindividual variability of chemical metabolism.

Cardiovascular Risk and Its Associated Factors in Health Care Workers in Colombia: A Study Protocol.

PubMed

Gamboa Delgado, Edna M; Rojas Sánchez, Lyda Z; Bermon Angarita, Anderson; Rangel Díaz, Yully Andrea; Jaraba Suárez, Silvia J; Serrano Díaz, Norma C; Vega Fernández, Evaristo

2015-07-30

Cardiovascular diseases are the leading cause of mortality worldwide, for this reason, they are a public health problem. In Colombia, cardiovascular diseases are the main cause of mortality, having a death rate of 152 deaths per 100,000 population. There are 80% of these cardiovascular events that are considered avoidable. The objective of the study is to determine the prevalence of the cardiovascular risk and its associated factors among the institution's workers in order to design and implement interventions in the work environment which may achieve a decrease in such risk. An analytical cross-sectional study was designed to determine the cardiovascular risk and its associated factors among workers of a high complexity health care institution. A self-applied survey will be conducted considering sociodemographic aspects, physical activity, diet, alcohol consumption, smoking, level of perceived stress, and personal and family history. In a second appointment, a physical examination will be made, as well as anthropometric measurements and blood pressure determination. Also, blood samples for evaluating total and high density lipoprotein cholesterol, triglycerides, and fasting blood sugar will be taken. A ten-year global risk for cardiovascular disease will be determined using the Framingham score. A descriptive analysis of the population's characteristics and a stratified analysis by sex, age, and occupation will be made. Bivariate and multivariate analysis will be made using logistic regression models to evaluate the association between cardiovascular risk and the independent variables. The research protocol was approved by the Scientific and Technical Committee and the Ethics Committee on Research of the Fundación Cardiovascular de Colombia. The protocol has already received funding and the enrollment phase will begin in the coming months. The results of this study will give the foundation for the design, implementation, and evaluation of a program based on promoting healthy lifestyles, such as performing regular physical activity and healthy food intake in order to avoid and/or control the cardiovascular risk in the workers of a high complexity health care institution.

Design of risk communication strategies based on risk perception among farmers exposed to pesticides in Rio de Janeiro State, Brazil.

PubMed

Peres, Frederico; Rodrigues, Karla Meneses; da Silva Peixoto Belo, Mariana Soares; Moreira, Josino Costa; Claudio, Luz

2013-01-01

This study aims to assess pesticide exposure risk perception among farmers from three rural areas of Nova Friburgo, Rio de Janeiro State, Brazil. Data were collected through semi-structured interviews with 66 adults and participatory workshops with 27 teenagers and analyzed through content analysis techniques. Systematized results were discussed at local meetings, and two risk communication initiatives were devised. Study results demonstrated the use of defensive strategies by men and a diminished risk perception among women. Teenagers relied on parents to develop their own work practices. These findings supported the importance of cultural and social determinants of farmers' understandings of risk and of the relevance of different pesticide exposure pathways. Risk perceptions and work practices are strongly influenced by local cultural patterns and, therefore, must be taken into account when developing effective intervention strategies, including risk communication initiatives. Copyright © 2012 Wiley Periodicals, Inc.

The Impact of Teacher Conflict Styles on Student Discipline Outcomes: A Triangulation Study of the Symbolic Interaction of the Teacher as Agent within the School Organizational Structure: A Case Study of Teacher Conflict Style Selection and the Discipline Outcomes That Result from Each Conflict Style

ERIC Educational Resources Information Center

Borrazzo, Marie E.

2005-01-01

Research was centered on "at risk" students enrolled in an Academy that was designed to specifically meet "at risk" student needs. Teacher response styles during the discipline process was the center of the research given that "at risk" students are suspended more frequently than students typically falling into the "regular" student population.…

Outrage Factors in Government Press Releases of Food Risk and Their Influence on News Media Coverage.

PubMed

Ju, Youngkee; Lim, Jeongsub; Shim, Minsun; You, Myoungsoon

2015-08-01

An appropriate level of risk perception should be a critical issue in modern "risk society." There have been many studies on the influences on risk perception. This study investigates whether risk communication scholar Dr. Peter Sandman's outrage factors intensify journalistic attention to health risks from food consumption. A content analysis of a health institution's press releases was conducted to examine 15 outrage factors of food risks conveyed in the governmental risk communication. In addition, the news stories covering the food risks informed by the press releases were calculated to evaluate the relation between outrage factors of a risk and the number of news stories covering the risk. Results showed that controllability was the most salient outrage factor, followed by trust, voluntariness, familiarity, and human origin; the greater the outrage score of a risk, the more news stories of the risk. For individual outrage factors, a risk with an implication of catastrophic potential was associated with an increase of news stories. Food providers' distrustful behaviors also influenced journalistic attention to the food risks. The implication of the findings to health message designers is discussed.

Interventions for Enhancing Adherence to Antiretroviral Therapy (ART): A Systematic Review of High Quality Studies

PubMed Central

Sivaramalingam, Bhairavi; Navarro, Tamara; Hobson, Nicholas; Keepanasseril, Arun; Wilczynski, Nancy J.; Haynes, R. Brian

2015-01-01

Abstract We sought to review the effectiveness of interventions designed to improve adherence to antiretroviral therapy (ART) from studies included in a recent Cochrane review that reported a clinical and an adherence outcome, with at least 80% follow-up for 6 months or more. Data were extracted independently and in duplicate, with an adjudicator for disagreements. Risk of bias was assessed using the Cochrane Risk of Bias tool. Of 182 relevant studies in the Cochrane review, 49 were related to ART. Statistical pooling was not warranted due to heterogeneity in interventions, participants, treatments, adherence measures and outcomes. Many studies had high risk of bias in elements of design and outcome ascertainment. Only 10 studies improved both adherence and clinical outcomes. These used the following interventions: adherence counselling (two studies); a once-daily regimen (compared to twice daily); text messaging; web-based cognitive behavioral intervention; face-to-face multi-session intensive behavioral interventions (two studies); contingency management; modified directly observed therapy; and nurse-delivered home visits combined with telephone calls. Patient-related adherence interventions were the most frequently tested. Uniform adherence measures and higher quality studies of younger populations are encouraged. PMID:25825938

Maternal DNA hypomethylation and congenital heart defects

PubMed Central

Chowdhury, Shimul; Cleves, Mario A.; MacLeod, Stewart L.; James, S. Jill; Zhao, Weizhi; Hobbs, Charlotte A.

2011-01-01

Background Congenital heart defects (CHDs) are among the most prevalent and serious of birth defects. Multiple maternal factors are thought to contribute to CHD development including folate intake. Maternal DNA methylation, which is dependent on folate metabolism, may impact the risk of CHDs. Objective Our study was designed to determine whether maternal long interspersed nucleotide elements-1 (LINE-1) DNA hypomethylation is associated with increased occurrence of non-syndromic CHDs and whether maternal folate-dependent metabolites are correlated with DNA methylation status. Design Using a case-control study design, we measured global DNA methylation status among mothers whose pregnancies were affected by non-syndromic CHDs (n=180) and mothers of unaffected pregnancies (n=187). Methylation of LINE-1 was used as a surrogate marker of global DNA methylation status. The association between DNA methylation and CHD risk was determined while adjusting for selected lifestyle factors. Results LINE-1 DNA methylation was significantly lower in cases compared with controls (p=0.049). After covariate adjustments, a significant difference between cases and controls remained (p=0.010). Among women with LINE-1 methylation in the lowest decile of DNA methylation, the estimated risk of having a CHD-affected pregnancy was almost twice that of women in all other deciles (OR=1.91; 95% CI: 1.03, 3.58). Conclusions Our findings indicate that maternal LINE-1 DNA hypomethylation is associated with an increased risk of CHDs. Future studies investigating the association between maternal DNA methylation patterns and CHDs should be pursued. PMID:21254366

Creating the Action Model for High Risk Infant Follow Up Program in Iran

PubMed Central

Heidarzadeh, Mohammad; Jodiery, Behzad; Mirnia, Kayvan; Akrami, Forouzan; Hosseini, Mohammad Bagher; Heidarabadi, Seifollah; HabibeLahi, Abbas

2013-01-01

Abstract Background Intervention in early childhood development as one of the social determinants of health, is important for reducing social gap and inequity. In spite of increasingly developing intensive neonatal care wards and decreasing neonatal mortality rate, there is no follow up program in Iran. This study was carreid out to design high risk infants follow up care program with the practical aim of creating an model action for whole country, in 2012. Methods This qualitative study has been done by the Neonatal Department of the Deputy of Public Health in cooperation with Pediatrics Health Research Center of Tabriz University of Medical Sciences, Iran. After study of international documents, consensus agreement about adapted program for Iran has been accomplished by focus group discussion and attended Delphi agreement technique. After compiling primary draft included evidence based guidelines and executive plan, 14 sessions including expert panels were hold to finalize the program. Results After finalizing the program, high risk infants follow up care service package has been designed in 3 chapters: Evidence based clinical guidelines; eighteen main clinical guidelines and thirteen subsidiaries clinical guidelines, executive plan; 6 general, 6 following up and 5 backup processes. Education program including general and especial courses for care givers and follow up team, and family education processes. Conclusion We designed and finalized high risk infants follow up care service package. It seems to open a way to extend it to whole country. PMID:26171344

Regression dilution bias: tools for correction methods and sample size calculation.

PubMed

Berglund, Lars

2012-08-01

Random errors in measurement of a risk factor will introduce downward bias of an estimated association to a disease or a disease marker. This phenomenon is called regression dilution bias. A bias correction may be made with data from a validity study or a reliability study. In this article we give a non-technical description of designs of reliability studies with emphasis on selection of individuals for a repeated measurement, assumptions of measurement error models, and correction methods for the slope in a simple linear regression model where the dependent variable is a continuous variable. Also, we describe situations where correction for regression dilution bias is not appropriate. The methods are illustrated with the association between insulin sensitivity measured with the euglycaemic insulin clamp technique and fasting insulin, where measurement of the latter variable carries noticeable random error. We provide software tools for estimation of a corrected slope in a simple linear regression model assuming data for a continuous dependent variable and a continuous risk factor from a main study and an additional measurement of the risk factor in a reliability study. Also, we supply programs for estimation of the number of individuals needed in the reliability study and for choice of its design. Our conclusion is that correction for regression dilution bias is seldom applied in epidemiological studies. This may cause important effects of risk factors with large measurement errors to be neglected.

Developing a national strategy to prevent dementia: Leon Thal Symposium 2009.

PubMed

Khachaturian, Zaven S; Barnes, Deborah; Einstein, Richard; Johnson, Sterling; Lee, Virginia; Roses, Allen; Sager, Mark A; Shankle, William R; Snyder, Peter J; Petersen, Ronald C; Schellenberg, Gerard; Trojanowski, John; Aisen, Paul; Albert, Marilyn S; Breitner, John C S; Buckholtz, Neil; Carrillo, Maria; Ferris, Steven; Greenberg, Barry D; Grundman, Michael; Khachaturian, Ara S; Kuller, Lewis H; Lopez, Oscar L; Maruff, Paul; Mohs, Richard C; Morrison-Bogorad, Marcelle; Phelps, Creighton; Reiman, Eric; Sabbagh, Marwan; Sano, Mary; Schneider, Lon S; Siemers, Eric; Tariot, Pierre; Touchon, Jacques; Vellas, Bruno; Bain, Lisa J

2010-03-01

Among the major impediments to the design of clinical trials for the prevention of Alzheimer's disease (AD), the most critical is the lack of validated biomarkers, assessment tools, and algorithms that would facilitate identification of asymptomatic individuals with elevated risk who might be recruited as study volunteers. Thus, the Leon Thal Symposium 2009 (LTS'09), on October 27-28, 2009 in Las Vegas, Nevada, was convened to explore strategies to surmount the barriers in designing a multisite, comparative study to evaluate and validate various approaches for detecting and selecting asymptomatic people at risk for cognitive disorders/dementia. The deliberations of LTS'09 included presentations and reviews of different approaches (algorithms, biomarkers, or measures) for identifying asymptomatic individuals at elevated risk for AD who would be candidates for longitudinal or prevention studies. The key nested recommendations of LTS'09 included: (1) establishment of a National Database for Longitudinal Studies as a shared research core resource; (2) launch of a large collaborative study that will compare multiple screening approaches and biomarkers to determine the best method for identifying asymptomatic people at risk for AD; (3) initiation of a Global Database that extends the concept of the National Database for Longitudinal Studies for longitudinal studies beyond the United States; and (4) development of an educational campaign that will address public misconceptions about AD and promote healthy brain aging. 2010. Published by Elsevier Inc.

An analysis of characteristics of post-authorisation studies registered on the ENCePP EU PAS Register

PubMed Central

Carroll, Robert; Ramagopalan, Sreeram V.; Cid-Ruzafa, Javier; Lambrelli, Dimitra; McDonald, Laura

2017-01-01

Background: The objective of this study was to investigate the study design characteristics of Post-Authorisation Studies (PAS) requested by the European Medicines Agency which were recorded on the European Union (EU) PAS Register held by the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP). Methods: We undertook a cross-sectional descriptive analysis of all studies registered on the EU PAS Register as of 18 th October 2016. Results: We identified a total of 314 studies on the EU PAS Register, including 81 (26%) finalised, 160 (51%) ongoing and 73 (23%) planned. Of those studies identified, 205 (65%) included risk assessment in their scope, 133 (42%) included drug utilisation and 94 (30%) included effectiveness evaluation. Just over half of the studies (175; 56%) used primary data capture, 135 (43%) used secondary data and 4 (1%) used a hybrid design combining both approaches. Risk assessment and effectiveness studies were more likely to use primary data capture (60% and 85% respectively as compared to 39% and 14% respectively for secondary). The converse was true for drug utilisation studies where 59% were secondary vs. 39% for primary. For type 2 diabetes mellitus, database studies were more commonly used (80% vs 3% chart review, 3% hybrid and 13% primary data capture study designs) whereas for studies in oncology, primary data capture were more likely to be used (85% vs 4% chart review, and 11% database study designs). Conclusions: Results of this analysis show that PAS design varies according to study objectives and therapeutic area. PMID:29188016

Alcohol demand and risk preference.

PubMed

Dave, Dhaval; Saffer, Henry

2008-12-01

Both economists and psychologists have studied the concept of risk preference. Economists categorize individuals as more or less risk-tolerant based on the marginal utility of income. Psychologists categorize individuals' propensity towards risk based on harm avoidance, novelty seeking and reward dependence traits. The two concepts of risk are related, although the instruments used for empirical measurement are quite different. Psychologists have found risk preference to be an important determinant of alcohol consumption; however economists have not included risk preference in studies of alcohol demand. This is the first study to examine the effect of risk preference on alcohol consumption in the context of a demand function. The specifications employ multiple waves from the Panel Study of Income Dynamics (PSID) and the Health and Retirement Study (HRS), which permit the estimation of age-specific models based on nationally representative samples. Both of these data sets include a unique and consistent survey instrument designed to directly measure risk preference in accordance with the economist's definition. This study estimates the direct impact of risk preference on alcohol demand and also explores how risk preference affects the price elasticity of demand. The empirical results indicate that risk preference has a significant negative effect on alcohol consumption, with the prevalence and consumption among risk-tolerant individuals being 6-8% higher. Furthermore, the tax elasticity is similar across both risk-averse and risk-tolerant individuals. This suggests that tax policies are as equally effective in deterring alcohol consumption among those who have a higher versus a lower propensity for alcohol use.

Asteroid Deflection Mission Design Considering On-Ground Risks

NASA Astrophysics Data System (ADS)

Rumpf, Clemens; Lewis, Hugh G.; Atkinson, Peter

The deflection of an Earth-threatening asteroid requires high transparency of the mission design process. The goal of such a mission is to move the projected point of impact over the face of Earth until the asteroid is on a miss trajectory. During the course of deflection operations, the projected point of impact will match regions that were less affected before alteration of the asteroid’s trajectory. These regions are at risk of sustaining considerable damage if the deflecting spacecraft becomes non-operational. The projected impact point would remain where the deflection mission put it at the time of mission failure. Hence, all regions that are potentially affected by the deflection campaign need to be informed about this risk and should be involved in the mission design process. A mission design compromise will have to be found that is acceptable to all affected parties (Schweickart, 2004). A software tool that assesses the on-ground risk due to deflection missions is under development. It will allow to study the accumulated on-ground risk along the path of the projected impact point. The tool will help determine a deflection mission design that minimizes the on-ground casualty and damage risk due to deflection operations. Currently, the tool is capable of simulating asteroid trajectories through the solar system and considers gravitational forces between solar system bodies. A virtual asteroid may be placed at an arbitrary point in the simulation for analysis and manipulation. Furthermore, the tool determines the asteroid’s point of impact and provides an estimate of the population at risk. Validation has been conducted against the solar system ephemeris catalogue HORIZONS by NASA’s Jet Propulsion Laboratory (JPL). Asteroids that are propagated over a period of 15 years show typical position discrepancies of 0.05 Earth radii relative to HORIZONS’ output. Ultimately, results from this research will aid in the identification of requirements for deflection missions that enable effective, minimum risk asteroid deflection. Schweickart, R. L. (2004). THE REAL DEFLECTION DILEMMA. In 2004 Planetary Defense Conference: Protecting Earth from Asteroids (pp. 1-6). Orange County, California. Retrieved from http://b612foundation.org/wp-content/uploads/2013/02/Real_Deflection_Dilemma.pdf

Pre- and posttest evaluation of a breast cancer risk assessment program for nurse practitioners.

PubMed

Edwards, Quannetta T; Seibert, Diane

2010-07-01

Numerous studies have shown that healthcare providers, including nurse practitioners (NPs) fail to provide breast cancer risk assessment (BrCRA) in primary care settings. A potential barrier to the use of BrCRA is insufficient knowledge or training of risk assessment. The purpose of this study was to analyze the outcome of a BrCRA program developed to enhance NPs' knowledge of risk assessment and use of empiric risk assessment models. Thirty-five NPs participated in a before-after (pretest-posttest design) study evaluating the effectiveness of a BrCRA education program conducted at a national NP conference. Demographics, pre/post knowledge, and course satisfaction measures were all examined as a part of this pilot study. Continuing education through the implementation of a BrCRA program significantly increased NPs knowledge in assessing breast cancer risk and the use of empiric risk assessment models. Many healthcare providers, including NPs, are inadequately prepared to assess a woman's risk for breast cancer. Understanding breast cancer risk assessment is essential if NPs are to provide appropriate counseling, management, and referral strategies needed to reduce a woman's risk for developing the disease. Continuing education provides one means to enhance NP's knowledge of BrCRA.

Risk scores for outcome in bacterial meningitis: Systematic review and external validation study.

PubMed

Bijlsma, Merijn W; Brouwer, Matthijs C; Bossuyt, Patrick M; Heymans, Martijn W; van der Ende, Arie; Tanck, Michael W T; van de Beek, Diederik

2016-11-01

To perform an external validation study of risk scores, identified through a systematic review, predicting outcome in community-acquired bacterial meningitis. MEDLINE and EMBASE were searched for articles published between January 1960 and August 2014. Performance was evaluated in 2108 episodes of adult community-acquired bacterial meningitis from two nationwide prospective cohort studies by the area under the receiver operating characteristic curve (AUC), the calibration curve, calibration slope or Hosmer-Lemeshow test, and the distribution of calculated risks. Nine risk scores were identified predicting death, neurological deficit or death, or unfavorable outcome at discharge in bacterial meningitis, pneumococcal meningitis and invasive meningococcal disease. Most studies had shortcomings in design, analyses, and reporting. Evaluation showed AUCs of 0.59 (0.57-0.61) and 0.74 (0.71-0.76) in bacterial meningitis, 0.67 (0.64-0.70) in pneumococcal meningitis, and 0.81 (0.73-0.90), 0.82 (0.74-0.91), 0.84 (0.75-0.93), 0.84 (0.76-0.93), 0.85 (0.75-0.95), and 0.90 (0.83-0.98) in meningococcal meningitis. Calibration curves showed adequate agreement between predicted and observed outcomes for four scores, but statistical tests indicated poor calibration of all risk scores. One score could be recommended for the interpretation and design of bacterial meningitis studies. None of the existing scores performed well enough to recommend routine use in individual patient management. Copyright © 2016 The British Infection Association. Published by Elsevier Ltd. All rights reserved.

Rationale, design and methods of the HEALTHY study behavior intervention component

USDA-ARS?s Scientific Manuscript database

HEALTHY was a multi-center primary prevention trial designed to reduce risk factors for type 2 diabetes in adolescents. Seven centers each recruited six middle schools that were randomized to either intervention or control. The HEALTHY intervention integrated multiple components in nutrition, physic...

Methods to Enhance Students' Entrepreneurial Mindset: A Swedish Example

ERIC Educational Resources Information Center

Lindberg, Erik; Bohman, Håkan; Hultén, Peter

2017-01-01

Purpose: The purpose of this study is to examine the effects of intervention methods in an entrepreneurship education (EE) course that was designed to enhance the students' entrepreneurial mindset by targeting their opportunity identification, creativity and risk management capabilities (RMC). Design/methodology/approach: The authors formulate…

Early detection network design and search strategy issues

EPA Science Inventory

We conducted a series of field and related modeling studies (2005-2012) to evaluate search strategies for Great Lakes coastal ecosystems that are at risk of invasion by non-native aquatic species. In developing a network, we should design to achieve an acceptable limit of detect...

Eliciting Affect via Immersive Virtual Reality: A Tool for Adolescent Risk Reduction

PubMed Central

Houck, Christopher D.; Barker, David H.; Garcia, Abbe Marrs; Spitalnick, Josh S.; Curtis, Virginia; Roye, Scott; Brown, Larry K.

2014-01-01

Objective A virtual reality environment (VRE) was designed to expose participants to substance use and sexual risk-taking cues to examine the utility of VR in eliciting adolescent physiological arousal. Methods 42 adolescents (55% male) with a mean age of 14.54 years (SD = 1.13) participated. Physiological arousal was examined through heart rate (HR), respiratory sinus arrhythmia (RSA), and self-reported somatic arousal. A within-subject design (neutral VRE, VR party, and neutral VRE) was utilized to examine changes in arousal. Results The VR party demonstrated an increase in physiological arousal relative to a neutral VRE. Examination of individual segments of the party (e.g., orientation, substance use, and sexual risk) demonstrated that HR was significantly elevated across all segments, whereas only the orientation and sexual risk segments demonstrated significant impact on RSA. Conclusions This study provides preliminary evidence that VREs can be used to generate physiological arousal in response to substance use and sexual risk cues. PMID:24365699

Social network recruitment for Yo Puedo - an innovative sexual health intervention in an underserved urban neighborhood: sample and design implications

PubMed Central

Minnis, Alexandra M.; vanDommelen-Gonzalez, Evan; Luecke, Ellen; Cheng, Helen; Dow, William; Bautista-Arredondo, Sergio; Padian, Nancy S.

2016-01-01

Most existing evidence-based sexual health interventions focus on individual-level behavior, even though there is substantial evidence that highlights the influential role of social environments in shaping adolescents’ behaviors and reproductive health outcomes. We developed Yo Puedo, a combined conditional cash transfer (CCT) and life skills intervention for youth to promote educational attainment, job training, and reproductive health wellness that we then evaluated for feasibility among 162 youth aged 16–21 years in a predominantly Latino community in San Francisco, CA. The intervention targeted youth’s social networks and involved recruitment and randomization of small social network clusters. In this paper we describe the design of the feasibility study and report participants’ baseline characteristics. Furthermore, we examined the sample and design implications of recruiting social network clusters as the unit of randomization. Baseline data provide evidence that we successfully enrolled high risk youth using a social network recruitment approach in community and school-based settings. Nearly all participants (95%) were high risk for adverse educational and reproductive health outcomes based on multiple measures of low socioeconomic status (81%) and/or reported high risk behaviors (e.g., gang affiliation, past pregnancy, recent unprotected sex, frequent substance use) (62%). We achieved variability in the study sample through heterogeneity in recruitment of the index participants, whereas the individuals within the small social networks of close friends demonstrated substantial homogeneity across sociodemographic and risk profile characteristics. Social networks recruitment was feasible and yielded a sample of high risk youth willing to enroll in a randomized study to evaluate a novel sexual health intervention. PMID:25358834

Quantitative microbial risk assessment for Escherichia coli O157:H7, salmonella, and Listeria monocytogenes in leafy green vegetables consumed at salad bars.

PubMed

Franz, E; Tromp, S O; Rijgersberg, H; van der Fels-Klerx, H J

2010-02-01

Fresh vegetables are increasingly recognized as a source of foodborne outbreaks in many parts of the world. The purpose of this study was to conduct a quantitative microbial risk assessment for Escherichia coli O157:H7, Salmonella, and Listeria monocytogenes infection from consumption of leafy green vegetables in salad from salad bars in The Netherlands. Pathogen growth was modeled in Aladin (Agro Logistics Analysis and Design Instrument) using time-temperature profiles in the chilled supply chain and one particular restaurant with a salad bar. A second-order Monte Carlo risk assessment model was constructed (using @Risk) to estimate the public health effects. The temperature in the studied cold chain was well controlled below 5 degrees C. Growth of E. coli O157:H7 and Salmonella was minimal (17 and 15%, respectively). Growth of L. monocytogenes was considerably greater (194%). Based on first-order Monte Carlo simulations, the average number of cases per year in The Netherlands associated the consumption leafy greens in salads from salad bars was 166, 187, and 0.3 for E. coli O157:H7, Salmonella, and L. monocytogenes, respectively. The ranges of the average number of annual cases as estimated by second-order Monte Carlo simulation (with prevalence and number of visitors as uncertain variables) were 42 to 551 for E. coli O157:H7, 81 to 281 for Salmonella, and 0.1 to 0.9 for L. monocytogenes. This study included an integration of modeling pathogen growth in the supply chain of fresh leafy vegetables destined for restaurant salad bars using software designed to model and design logistics and modeling the public health effects using probabilistic risk assessment software.

Learning from Failures: Archiving and Designing with Failure and Risk

NASA Technical Reports Server (NTRS)

VanWie, Michael; Bohm, Matt; Barrientos, Francesca; Turner, Irem; Stone, Robert

2005-01-01

Identifying and mitigating risks during conceptual design remains an ongoing challenge. This work presents the results of collaborative efforts between The University of Missouri-Rolla and NASA Ames Research Center to examine how an early stage mission design team at NASA addresses risk, and, how a computational support tool can assist these designers in their tasks. Results of our observations are given in addition to a brief example of our implementation of a repository based computational tool that allows users to browse and search through archived failure and risk data as related to either physical artifacts or functionality.

Multi-variant study of obesity risk genes in African Americans: The Jackson Heart Study.

PubMed

Liu, Shijian; Wilson, James G; Jiang, Fan; Griswold, Michael; Correa, Adolfo; Mei, Hao

2016-11-30

Genome-wide association study (GWAS) has been successful in identifying obesity risk genes by single-variant association analysis. For this study, we designed steps of analysis strategy and aimed to identify multi-variant effects on obesity risk among candidate genes. Our analyses were focused on 2137 African American participants with body mass index measured in the Jackson Heart Study and 657 common single nucleotide polymorphisms (SNPs) genotyped at 8 GWAS-identified obesity risk genes. Single-variant association test showed that no SNPs reached significance after multiple testing adjustment. The following gene-gene interaction analysis, which was focused on SNPs with unadjusted p-value<0.10, identified 6 significant multi-variant associations. Logistic regression showed that SNPs in these associations did not have significant linear interactions; examination of genetic risk score evidenced that 4 multi-variant associations had significant additive effects of risk SNPs; and haplotype association test presented that all multi-variant associations contained one or several combinations of particular alleles or haplotypes, associated with increased obesity risk. Our study evidenced that obesity risk genes generated multi-variant effects, which can be additive or non-linear interactions, and multi-variant study is an important supplement to existing GWAS for understanding genetic effects of obesity risk genes. Copyright © 2016 Elsevier B.V. All rights reserved.

Quantitative Relationship Between Cumulative Risk Alleles Based on Genome-Wide Association Studies and Type 2 Diabetes Mellitus: A Systematic Review and Meta-analysis.

PubMed

Kodama, Satoru; Fujihara, Kazuya; Ishiguro, Hajime; Horikawa, Chika; Ohara, Nobumasa; Yachi, Yoko; Tanaka, Shiro; Shimano, Hitoshi; Kato, Kiminori; Hanyu, Osamu; Sone, Hirohito

2018-01-05

Many epidemiological studies have assessed the genetic risk of having undiagnosed or of developing type 2 diabetes mellitus (T2DM) using several single nucleotide polymorphisms (SNPs) based on findings of genome-wide association studies (GWAS). However, the quantitative association of cumulative risk alleles (RAs) of such SNPs with T2DM risk has been unclear. The aim of this meta-analysis is to review the strength of the association between cumulative RAs and T2DM risk. Systematic literature searches were conducted for cross-sectional or longitudinal studies that examined odds ratios (ORs) for T2DM in relation to genetic profiles. Logarithm of the estimated OR (log OR) of T2DM for 1 increment in RAs carried (1-ΔRA) in each study was pooled using a random-effects model. There were 46 eligible studies that included 74,880 cases among 249,365 participants. In 32 studies with a cross-sectional design, the pooled OR for T2DM morbidity for 1-ΔRA was 1.16 (95% confidence interval [CI], 1.13-1.19). In 15 studies that had a longitudinal design, the OR for incident T2DM was 1.10 (95% CI, 1.08-1.13). There was large heterogeneity in the magnitude of log OR (P < 0.001 for both cross-sectional studies and longitudinal studies). The top 10 commonly used genes significantly explained the variance in the log OR (P = 0.04 for cross-sectional studies; P = 0.006 for longitudinal studies). The current meta-analysis indicated that carrying 1-ΔRA in T2DM-associated SNPs was associated with a modest risk of prevalent or incident T2DM, although the heterogeneity in the used genes among studies requires us to interpret the results with caution.

Quantitative Relationship Between Cumulative Risk Alleles Based on Genome-Wide Association Studies and Type 2 Diabetes Mellitus: A Systematic Review and Meta-analysis

PubMed Central

Kodama, Satoru; Fujihara, Kazuya; Ishiguro, Hajime; Horikawa, Chika; Ohara, Nobumasa; Yachi, Yoko; Tanaka, Shiro; Shimano, Hitoshi; Kato, Kiminori; Hanyu, Osamu; Sone, Hirohito

2018-01-01

Many epidemiological studies have assessed the genetic risk of having undiagnosed or of developing type 2 diabetes mellitus (T2DM) using several single nucleotide polymorphisms (SNPs) based on findings of genome-wide association studies (GWAS). However, the quantitative association of cumulative risk alleles (RAs) of such SNPs with T2DM risk has been unclear. The aim of this meta-analysis is to review the strength of the association between cumulative RAs and T2DM risk. Systematic literature searches were conducted for cross-sectional or longitudinal studies that examined odds ratios (ORs) for T2DM in relation to genetic profiles. Logarithm of the estimated OR (log OR) of T2DM for 1 increment in RAs carried (1-ΔRA) in each study was pooled using a random-effects model. There were 46 eligible studies that included 74,880 cases among 249,365 participants. In 32 studies with a cross-sectional design, the pooled OR for T2DM morbidity for 1-ΔRA was 1.16 (95% confidence interval [CI], 1.13–1.19). In 15 studies that had a longitudinal design, the OR for incident T2DM was 1.10 (95% CI, 1.08–1.13). There was large heterogeneity in the magnitude of log OR (P < 0.001 for both cross-sectional studies and longitudinal studies). The top 10 commonly used genes significantly explained the variance in the log OR (P = 0.04 for cross-sectional studies; P = 0.006 for longitudinal studies). The current meta-analysis indicated that carrying 1-ΔRA in T2DM-associated SNPs was associated with a modest risk of prevalent or incident T2DM, although the heterogeneity in the used genes among studies requires us to interpret the results with caution. PMID:29093303

Noninferiority trial designs for odds ratios and risk differences.

PubMed

Hilton, Joan F

2010-04-30

This study presents constrained maximum likelihood derivations of the design parameters of noninferiority trials for binary outcomes with the margin defined on the odds ratio (ψ) or risk-difference (δ) scale. The derivations show that, for trials in which the group-specific response rates are equal under the point-alternative hypothesis, the common response rate, π(N), is a fixed design parameter whose value lies between the control and experimental rates hypothesized at the point-null, {π(C), π(E)}. We show that setting π(N) equal to the value of π(C) that holds under H(0) underestimates the overall sample size requirement. Given {π(C), ψ} or {π(C), δ} and the type I and II error rates, or algorithm finds clinically meaningful design values of π(N), and the corresponding minimum asymptotic sample size, N=n(E)+n(C), and optimal allocation ratio, γ=n(E)/n(C). We find that optimal allocations are increasingly imbalanced as ψ increases, with γ(ψ)<1 and γ(δ)≈1/γ(ψ), and that ranges of allocation ratios map to the minimum sample size. The latter characteristic allows trialists to consider trade-offs between optimal allocation at a smaller N and a preferred allocation at a larger N. For designs with relatively large margins (e.g. ψ>2.5), trial results that are presented on both scales will differ in power, with more power lost if the study is designed on the risk-difference scale and reported on the odds ratio scale than vice versa. 2010 John Wiley & Sons, Ltd.

Granulocyte-colony stimulating factor in the prevention of postoperative infectious complications and sub-optimal recovery from operation in patients with colorectal cancer and increased preoperative risk (ASA 3 and 4). Protocol for a controlled clinical trial developed by consensus of an international study group. Part two: design of the study.

PubMed

Bauhofer, A; Lorenz, W; Stinner, B; Rothmund, M; Koller, M; Sitter, H; Celik, I; Farndon, J R; Fingerhut, A; Hay, J M; Lefering, R; Lorijn, R; Nyström, P O; Schäfer, H; Schein, M; Solomkin, J; Troidl, H; Volk, H D; Wittmann, D H; Wyatt, J

2001-04-01

Presentation of a new type of a study protocol for evaluation of the effectiveness of an immune modifier (rhG-CSF, filgrastim): prevention of postoperative infectious complications and of sub-optimal recovery from operation in patients with colorectal cancer and increased preoperative risk (ASA 3 and 4). This part describes the design of the randomised, placebo controlled, double-blinded, single-centre study performed at an university hospital (n = 40 patients for each group). The trial design includes the following elements for a prototype protocol: * The study population is restricted to patients with colorectal cancer, including a left sided resection and an increased perioperative risk (ASA 3 and 4). * Patients are allocated by random to the control or treatment group. * The double blinding strategy of the trial is assessed by psychometric indices. * An endpoint construct with quality of life (EORTC QLQ-C30) and a recovery index (modified Mc Peek index) are used as primary endpoints. Qualitative analysis of clinical relevance of the endpoints is performed by both patients and doctors. * Statistical analysis uses an area under the curve (AUC) model for improvement of quality of life on leaving hospital and two and six months after operation. A confirmatory statistical model with quality of life as the first primary endpoint in the hierarchic test procedure is used. Expectations of patients and surgeons and the negative affect are analysed by social psychological scales. This study design differs from other trials on preoperative prophylaxis and postoperative recovery, and has been developed to try a new concept and avoid previous failures.

Systematic review of incidence and complications of herpes zoster: towards a global perspective

PubMed Central

Kawai, Kosuke; Gebremeskel, Berhanu G; Acosta, Camilo J

2014-01-01

Objective The objective of this study was to characterise the incidence rates of herpes zoster (HZ), also known as shingles, and risk of complications across the world. Design We systematically reviewed studies examining the incidence rates of HZ, temporal trends of HZ, the risk of complications including postherpetic neuralgia (PHN) and HZ-associated hospitalisation and mortality rates in the general population. The literature search was conducted using PubMed, EMBASE and the WHO library up to December 2013. Results We included 130 studies conducted in 26 countries. The incidence rate of HZ ranged between 3 and 5/1000 person-years in North America, Europe and Asia-Pacific, based on studies using prospective surveillance, electronic medical record data or administrative data with medical record review. A temporal increase in the incidence of HZ was reported in the past several decades across seven countries, often occurring before the introduction of varicella vaccination programmes. The risk of developing PHN varied from 5% to more than 30%, depending on the type of study design, age distribution of study populations and definition. More than 30% of patients with PHN experienced persistent pain for more than 1 year. The risk of recurrence of HZ ranged from 1% to 6%, with long-term follow-up studies showing higher risk (5–6%). Hospitalisation rates ranged from 2 to 25/100 000 person-years, with higher rates among elderly populations. Conclusions HZ is a significant global health burden that is expected to increase as the population ages. Future research with rigorous methods is important. PMID:24916088

The Nightingale study: rationale, study design and baseline characteristics of a prospective cohort study on shift work and breast cancer risk among nurses.

PubMed

Pijpe, Anouk; Slottje, Pauline; van Pelt, Cres; Stehmann, Floor; Kromhout, Hans; van Leeuwen, Flora E; Vermeulen, Roel C H; Rookus, Matti A

2014-01-29

Evidence for the carcinogenicity of shift work in humans is limited because of significant heterogeneity of the results, thus more in-depth research in needed. The Nightingale Study is a nationwide prospective cohort study on occupational exposures and risks of chronic diseases among female nurses and focuses on the potential association between shift work and risk of breast cancer. The study design, methods, and baseline characteristics of the cohort are described. The source population for the cohort comprised 18 to 65 year old women who were registered as having completed training to be a nurse in the nationwide register for healthcare professionals in the Netherlands. Eligible women were invited to complete a web-based questionnaire including full job history, a detailed section on all domains of shift work (shift system, cumulative exposure, and shift intensity) and potential confounding factors, and an informed consent form for linkage with national (disease) registries. Women were also asked to donate toenail clippings as a source of DNA for genetic analyses. Between October 6, 2011 and February 1, 2012, 31% of the 192,931 women who were invited to participate completed the questionnaire, yielding a sample size of 59,947 cohort members. The mean age of the participants was 46.9 year (standard deviation 11.0 years). Toenail clippings were provided by 23,439 participants (39%). Results from the Nightingale Study will contribute to the scientific evidence of potential shift work-related health risks among nurses and will help develop preventive measures and policy aimed at reducing these risks.

Association between the BRCA2 rs144848 polymorphism and cancer susceptibility: a meta-analysis.

PubMed

Li, Qiuyan; Guan, Rongwei; Qiao, Yuandong; Liu, Chang; He, Ning; Zhang, Xuelong; Jia, Xueyuan; Sun, Haiming; Yu, Jingcui; Xu, Lidan

2017-06-13

The BRCA2 gene plays an important role in cancer carcinogenesis, and polymorphisms in this gene have been associated with cancer risk. The BRCA2 rs144848 polymorphism has been associated with several cancers, but results have been inconsistent. In the present study, a meta-analysis was performed to assess the association between the rs144848 polymorphism and cancer risk. Literature was searched from the databases of PubMed, Embase and Google Scholar before April 2016. The fixed or random effects model was used to calculate pooled odd ratios on the basis of heterogeneity. Meta-regression, sensitivity analysis, subgroup analysis and publication bias assessment were also performed using STATA 11.0 software according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses 2009. A total of 40 relevant studies from 30 publications including 34,911 cases and 48,329 controls were included in the final meta-analysis. Among them, 22 studies focused on breast cancer, seven on ovarian cancer, five on non-Hodgkin lymphoma, and the remaining six studies examined various other cancers. The meta-analysis results showed that there were significant associations between the rs144848 polymorphism and cancer risk in all genetic models. Stratified by cancer type, the rs144848 polymorphism was associated with non-Hodgkin lymphoma. Stratified by study design, the allele model was associated with breast cancer risk in population-based studies. The meta-analysis suggests that the BRCA2 rs144848 polymorphism may play a role in cancer risk. Further well-designed studies are warranted to confirm these results.